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, 2005 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 o No þ
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule
12b-2 of the Exchange Act). Yes þ No 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 November 30, 2005, the registrant had 74,131,283 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. |
Restatement
As described in our Annual Report on Form 10-K for the year ended December 31, 2004, we have
restated our condensed consolidated financial statements for the first three quarters of 2004.
This Form 10-Q includes restated quarterly information for the three and six months ended June 30,
2004.
For further discussion of the effect of the restatement see Part 1, Item 1. Financial Statements,
Note 2 of Notes to Condensed Consolidated Financial Statements, Item 2. Managements Discussion and
Analysis of Financial Condition and Results of Operations and Item 4. Controls and Procedures.
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, |
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December 31, |
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2005 |
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2004 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
32,580 |
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$ |
92,310 |
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Short-term investments |
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35,694 |
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20,182 |
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Accounts receivable, net |
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21,016 |
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30,847 |
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Current portion of inventories, net |
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6,328 |
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7,155 |
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Other current assets |
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12,924 |
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17,713 |
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Total current assets |
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108,542 |
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168,207 |
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Restricted investments |
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1,826 |
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2,378 |
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Long-term portion of inventories, net |
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8,727 |
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4,617 |
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Property and equipment, net |
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22,927 |
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23,647 |
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Acquired technology and product rights, net |
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153,773 |
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127,443 |
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Other assets |
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5,928 |
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6,174 |
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Total assets |
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$ |
301,723 |
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$ |
332,466 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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Current liabilities: |
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Accounts payable |
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$ |
14,276 |
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$ |
17,352 |
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Accrued liabilities |
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42,864 |
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43,908 |
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Current portion of deferred revenue, net |
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153,372 |
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152,528 |
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Current portion of equipment financing obligations |
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2,638 |
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2,604 |
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Current portion of long-term debt |
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331 |
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320 |
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Total current liabilities |
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213,481 |
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216,712 |
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Long-term debt |
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166,919 |
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167,089 |
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Long-term portion of deferred revenue, net |
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4,357 |
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4,512 |
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Long-term portion of equipment financing obligations |
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3,910 |
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4,003 |
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Other long-term liabilities |
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3,101 |
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3,122 |
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Total liabilities |
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391,768 |
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395,438 |
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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, 2005 and December 31, 2004 |
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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, $0.001 par value; 200,000,000 shares authorized, 73,133,715 and
72,970,670 shares issued at June 30, 2005 and December 31, 2004 respectively |
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73 |
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73 |
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Additional paid-in capital |
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720,924 |
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719,952 |
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Accumulated other comprehensive (loss) income |
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(420 |
) |
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229 |
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Accumulated deficit |
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(822,056 |
) |
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(794,660 |
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(101,479 |
) |
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(74,406 |
) |
Treasury stock, at cost; 73,842 shares |
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(911 |
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(911 |
) |
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Total stockholders deficit |
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(102,390 |
) |
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(75,317 |
) |
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$ |
301,723 |
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$ |
332,466 |
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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 |
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Six Months Ended |
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June 30, |
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June 30, |
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2005 |
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2004 |
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2005 |
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2004 |
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(Restated) |
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(Restated) |
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Revenues: |
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Product sales |
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$ |
41,735 |
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$ |
29,299 |
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$ |
76,780 |
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$ |
54,238 |
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Collaborative research and development and other revenues |
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4,064 |
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2,975 |
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6,004 |
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5,451 |
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Total revenues |
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45,799 |
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32,274 |
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82,784 |
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59,689 |
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Operating costs and expenses: |
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Cost of products sold |
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10,667 |
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9,718 |
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21,732 |
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17,263 |
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Research and development |
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14,524 |
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16,566 |
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29,259 |
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34,083 |
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Selling, general and administrative |
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20,149 |
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18,116 |
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39,364 |
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32,821 |
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Co-promotion |
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6,966 |
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7,000 |
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14,706 |
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13,731 |
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Total operating costs and expenses |
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52,306 |
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51,400 |
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105,061 |
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97,898 |
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Loss from operations |
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(6,507 |
) |
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(19,126 |
) |
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(22,277 |
) |
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(38,209 |
) |
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Other income (expense): |
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Interest income |
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398 |
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208 |
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842 |
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439 |
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Interest expense |
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(3,030 |
) |
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(3,128 |
) |
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(6,157 |
) |
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(6,175 |
) |
Other, net |
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232 |
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(1 |
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233 |
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2 |
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Total other expense, net |
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(2,400 |
) |
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(2,921 |
) |
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(5,082 |
) |
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(5,734 |
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Loss before income taxes |
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(8,907 |
) |
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(22,047 |
) |
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(27,359 |
) |
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(43,943 |
) |
Income tax expense |
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(17 |
) |
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(18 |
) |
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(37 |
) |
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(34 |
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Net loss |
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$ |
(8,924 |
) |
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$ |
(22,065 |
) |
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$ |
(27,396 |
) |
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$ |
(43,977 |
) |
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Basic and diluted per share amounts: |
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Net loss |
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$ |
(0.12 |
) |
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$ |
(0.30 |
) |
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$ |
(0.37 |
) |
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$ |
(0.60 |
) |
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Weighted average number of common shares |
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74,036,753 |
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73,754,146 |
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73,976,939 |
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73,528,581 |
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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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2005 |
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2004 |
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(Restated) |
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Operating activities |
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Net loss |
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$ |
(27,396 |
) |
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$ |
(43,977 |
) |
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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6,806 |
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5,473 |
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Depreciation and amortization of property and equipment |
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1,865 |
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1,509 |
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Amortization of debt issuance costs |
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512 |
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478 |
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Gain on sale of investment |
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(233 |
) |
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Other |
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52 |
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64 |
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Changes in operating assets and liabilities: |
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Accounts receivable, net |
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9,831 |
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1,127 |
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Inventories, net |
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(3,283 |
) |
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(3,487 |
) |
Other current assets |
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4,789 |
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(107 |
) |
Accounts payable and accrued liabilities |
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(4,120 |
) |
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4,529 |
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Other liabilities |
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(14 |
) |
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|
32 |
|
Deferred revenue, net |
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|
689 |
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|
17,980 |
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Net cash used in operating activities |
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(10,502 |
) |
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(16,379 |
) |
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Investing activities |
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Purchases of short-term investments |
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(24,849 |
) |
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(25,880 |
) |
Proceeds from sale of short-term investments |
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9,683 |
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17,345 |
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(Increase) decrease in restricted investments |
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(170 |
) |
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4,581 |
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Purchases of property and equipment |
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(1,145 |
) |
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(2,021 |
) |
Payment to buy-down ONTAK royalty obligation |
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(33,000 |
) |
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Capitalized portion of payment of lasofoxifene royalty rights |
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(558 |
) |
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Other, net |
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146 |
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(332 |
) |
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Net cash used in investing activities |
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(49,893 |
) |
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(6,307 |
) |
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Financing activities |
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Principal payments on equipment financing obligations |
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(1,449 |
) |
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(1,297 |
) |
Proceeds from equipment financing arrangements |
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1,390 |
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|
2,469 |
|
Repayment of long-term debt |
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(159 |
) |
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(144 |
) |
Net proceeds from issuance of common stock |
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|
920 |
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|
4,622 |
|
Decrease in other long-term liabilities |
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(37 |
) |
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|
(74 |
) |
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Net cash provided by financing activities |
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|
665 |
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|
5,576 |
|
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Net decrease in cash and cash equivalents |
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|
(59,730 |
) |
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|
(17,110 |
) |
Cash and cash equivalents at beginning of period |
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|
92,310 |
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|
59,030 |
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Cash and cash equivalents at end of period |
|
$ |
32,580 |
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$ |
41,920 |
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Supplemental disclosure of cash flow information |
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Interest paid |
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$ |
5,208 |
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$ |
5,245 |
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|
See accompanying notes.
5
LIGAND PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
The accompanying condensed consolidated financial statements of Ligand Pharmaceuticals Incorporated
(the Company or Ligand) were prepared in accordance with instructions for Form 10-Q and,
therefore, do not include all information necessary for a complete presentation of financial
condition, results of operations, and cash flows in conformity with accounting principles generally
accepted in the United States of America. However, all adjustments, consisting of normal recurring
adjustments, which, in the opinion of management, are necessary for a fair presentation of the
condensed consolidated financial statements, have been included. The results of operations for the
three and six months ended June 30, 2005 and 2004 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,
2004.
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).
Use of Estimates. The preparation of consolidated financial statements in conformity with
generally accepted accounting principles requires the use of estimates and assumptions that affect
the reported amounts of assets and liabilities, including disclosure of contingent assets and
contingent liabilities, at the date of the consolidated financial statements and the reported
amounts of revenue and expenses during the reporting period. The Companys critical accounting
policies are those that are both most important to the Companys financial condition and results of
operations and require the most difficult, subjective or complex judgments on the part of
management in their application, often as a result of the need to make estimates about the effect
of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the
estimates or judgments used in the preparation of the consolidated financial statements, actual
results may materially vary from these estimates.
Loss Per Share. Net loss per share is computed using the weighted average number of common shares
outstanding. Basic and diluted net loss per share amounts are equivalent for the periods presented
as the inclusion of potential common shares in the number of shares used for the diluted
computation would be anti-dilutive. Potential common shares, the shares that would be issued upon
the conversion of convertible notes and the exercise of outstanding warrants and stock options,
were 32.5 million and 32.4 million at June 30, 2005 and December 31, 2004, respectively.
Guarantees and Indemnifications. The Company accounts for and discloses guarantees in accordance
with FASB Interpretation No. 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 (FIN 45). The following is a summary of the Companys
agreements that the Company has determined are within the scope of FIN 45:
Under its bylaws, the Company has agreed to indemnify its officers and directors for certain
events or occurrences arising as a result of the officers or directors serving in such capacity.
The term of the indemnification period is for the officers or directors lifetime. The maximum
potential amount of future payments the Company could be required to make under these
indemnification agreements is unlimited. However, the Company has a directors and officers
liability insurance policy that limits its exposure and enables it to recover a portion of any
future amounts paid. As a result of its insurance policy coverage, the Company believes the
estimated fair value of these indemnification agreements is minimal and has no liabilities recorded
for these agreements as of June 30, 2005 and December 31, 2004.
6
The Company enters into indemnification provisions under its agreements with other companies
in its ordinary course of business, typically with business partners, contractors, customers and
landlords. Under these provisions the Company generally indemnifies and holds harmless the
indemnified party for direct losses suffered or incurred by the indemnified party as a result of
the Companys activities or, in some cases, as a result of the indemnified partys activities under
the agreement. The maximum potential amount of future payments the Company could be required to
make under these indemnification provisions is unlimited. The Company has not incurred material
costs to defend lawsuits or settle claims related to these indemnification agreements. As a
result, the Company believes the estimated fair value of these agreements is minimal. Accordingly,
the Company has no liabilities recorded for these agreements as of June 30, 2005 and December 31,
2004.
Accounting for Stock-Based Compensation. The Company accounts for stock-based compensation in
accordance with Accounting Principles Board Opinion (APB) No. 25, Accounting for Stock Issued to
Employees, and FASB Interpretation No. 44, Accounting for Certain Transactions Involving Stock
Compensation.
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. 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 the Financial Accounting Standard Board statement Share-Based Payment
(SFAS 123R).
In accordance with SFAS No. 148, Accounting for Stock-Based Compensation-Transition and
Disclosure, the following table summarizes the Companys results on a pro forma basis as if it had
recorded compensation expense based upon the fair value at the grant date for awards under these
plans consistent with the methodology prescribed under SFAS No. 123, Accounting for Stock-Based
Compensation for the three and six months ended June 30, 2005 and 2004 (in thousands, except for
net loss per share information):
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
2004 |
|
|
|
2005 |
|
|
(Restated) |
|
|
2005 |
|
|
(Restated) |
|
Net loss, as reported |
|
$ |
(8,924 |
) |
|
$ |
(22,065 |
) |
|
$ |
(27,396 |
) |
|
$ |
(43,977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
(781 |
) |
|
|
(1,829 |
) |
|
|
(1,538 |
) |
|
|
(3,463 |
) |
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 |
) |
|
$ |
(23,894 |
) |
|
$ |
(41,389 |
) |
|
$ |
(47,440 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share as reported |
|
$ |
(0.12 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share pro forma |
|
$ |
(0.13 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.65 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents pro-forma unrecognized expense for accelerated options as of the date of
acceleration. |
The fair value for these options was estimated at the dates of grant using the Black-Scholes
option valuation model with the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2004 |
|
|
|
2004 |
|
|
2005 |
|
(Restated) |
|
2005 |
|
(Restated) |
Risk free interest rate |
|
3.7% |
|
3.8% |
|
3.7% |
|
3.8% |
Dividend yield |
|
|
|
|
|
|
|
|
Volatility |
|
73% |
|
75% |
|
73% |
|
75% |
Weighted average expected life |
|
5 years |
|
5 years |
|
5 years |
|
5 years |
The Black-Scholes option valuation model was developed for use in estimating the fair value of
traded options that have no vesting restrictions and are fully transferable. In addition, option
valuation models require the input of highly subjective assumptions including the expected stock
price volatility. Because the Companys employee stock options have characteristics significantly
different from those of traded options, and because changes in the subjective input assumptions can
materially affect the fair value estimate, in managements opinion, the existing models do not
necessarily provide a reliable single measure of the fair value of its employee stock options.
8
The following is a summary of the Companys stock option plan activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
Options exercisable |
|
|
Weighted average |
|
|
|
Shares |
|
|
exercise price |
|
|
at period end |
|
|
exercise price |
|
Balance at December 31, 2004 |
|
|
6,714,069 |
|
|
$ |
12.11 |
|
|
|
4,320,643 |
|
|
$ |
11.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
406,587 |
|
|
|
6.88 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(106,600 |
) |
|
|
6.27 |
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(248,913 |
) |
|
|
10.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005 |
|
|
6,765,143 |
|
|
$ |
11.96 |
|
|
|
5,701,426 |
|
|
$ |
12.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable. Accounts receivable consist of the following (in thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Trade accounts receivable |
|
$ |
2,265 |
|
|
$ |
25,860 |
|
Due from finance company |
|
|
19,750 |
|
|
|
6,084 |
|
Less: allowances |
|
|
(999 |
) |
|
|
(1,097 |
) |
|
|
|
|
|
|
|
|
|
$ |
21,016 |
|
|
$ |
30,847 |
|
|
|
|
|
|
|
|
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, |
|
|
|
2005 |
|
|
2004 |
|
Raw materials |
|
$ |
1,517 |
|
|
$ |
1,855 |
|
Work-in process |
|
|
7,861 |
|
|
|
2,302 |
|
Finished goods |
|
|
7,410 |
|
|
|
8,642 |
|
Less: inventory reserves |
|
|
(1,733 |
) |
|
|
(1,027 |
) |
|
|
|
|
|
|
|
|
|
|
15,055 |
|
|
|
11,772 |
|
Less: current portion |
|
|
(6,328 |
) |
|
|
(7,155 |
) |
|
|
|
|
|
|
|
Long-term portion of inventories, net |
|
$ |
8,727 |
|
|
$ |
4,617 |
|
|
|
|
|
|
|
|
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
approximately 4 years. 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, 2005,
approximately $0.5 million of ONTAK finished goods inventory was written off due to the Companys
updated assessment in December of 2005 of the timing of certain clinical trials. As of June 30,
2005 and December 31, 2004, total ONTAK inventory amounted to approximately $8.0 million, and $6.1
million, respectively, of which $5.7 million and $4.1 million is classified as long-term,
respectively.
During 2005, the Company also manufactured a higher than normal amount of drug substance
(bexarotene) for Targretin capsules in the event the Companys NSCLC clinical trials were
successful. As further discussed in Note 5, 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, 2005 and December 31, 2004, total Targretin capsules inventory
amounted to approximately $4.7 million and $1.6 million, respectively, of which $3.0 million and
$0.5 million is classified as long-term, respectively.
9
Other Current Assets. Other current assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Deferred royalty cost |
|
$ |
5,363 |
|
|
$ |
9,363 |
|
Deferred cost of products sold |
|
|
4,268 |
|
|
|
4,784 |
|
Prepaid insurance |
|
|
495 |
|
|
|
1,024 |
|
Prepaid other |
|
|
2,137 |
|
|
|
2,102 |
|
Other |
|
|
661 |
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
$ |
12,924 |
|
|
$ |
17,713 |
|
|
|
|
|
|
|
|
Other Assets. Other assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Prepaid royalty buyout, net (1) |
|
$ |
3,006 |
|
|
$ |
2,584 |
|
Debt issue costs, net |
|
|
2,719 |
|
|
|
3,231 |
|
Other |
|
|
203 |
|
|
|
359 |
|
|
|
|
|
|
|
|
|
|
$ |
5,928 |
|
|
$ |
6,174 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
In January 2005, Ligand paid The Salk Institute $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 filing in the United States (NDA) 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 The Salk Institute, approximately $0.6 million, as development
expense in the first quarter of 2005. The balance of approximately $0.5 million was
capitalized and will be amortized over the period any such royalties are received from
Pfizer for the vaginal atrophy indication. |
Amortization of debt issues costs was $0.3 million and $0.2 million for the three months ended
June 30, 2005 and 2004 and $0.5 million and $0.5 million for the six months ended June 30, 2005 and
2004, respectively. Estimated annual amortization of these assets in each of the years in the
period from 2005 through 2007 is approximately $1.1 million.
Acquired Technology and Product Rights. In accordance with SFAS No. 142, Goodwill and Other
Intangibles, the Company amortizes intangible assets with finite lives in a manner that reflects
the pattern in which the economic benefits of the assets are consumed or otherwise used up. If
that pattern cannot be reliably determined, the assets are amortized using the straight-line
method.
Acquired technology and product rights as of June 30, 2005 include payments totaling $33.0
million to Lilly in exchange for the elimination of the Companys ONTAK royalty obligations in 2005
and a reduced reverse-tiered royalty scale on ONTAK sales in the U.S. thereafter. See Note 4
Royalty Agreements (Note 4). 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 4. 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
10
were acquired and otherwise
represents the period estimated to be benefited. Specifically, the Company is amortizing its ONTAK
asset through June 2014 which is approximate to the expiration date of its U.S. patent of December
2014. The AVINZA asset is being amortized through November 2017, the expiration of its U.S.
patent. Acquired technology and product rights consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
AVINZA |
|
$ |
114,437 |
|
|
$ |
114,437 |
|
Less accumulated amortization |
|
|
(19,910 |
) |
|
|
(16,096 |
) |
|
|
|
|
|
|
|
|
|
|
94,527 |
|
|
|
98,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONTAK |
|
|
78,312 |
|
|
|
45,312 |
|
Less accumulated amortization |
|
|
(19,066 |
) |
|
|
(16,210 |
) |
|
|
|
|
|
|
|
|
|
|
59,246 |
|
|
|
29,102 |
|
|
|
|
|
|
|
|
|
|
$ |
153,773 |
|
|
$ |
127,443 |
|
|
|
|
|
|
|
|
Amortization of acquired technology and product rights was $3.5 million and $6.7 million for
the three and six months ended June 30, 2005, respectively, and $2.7 million and $5.3 million for
the same 2004 periods, respectively. Estimated annual amortization for these assets in each of the
years in the period from 2006 through 2009 is approximately $14.0 million and a total of $90.7
million thereafter.
Deferred Revenue, Net. Under the sell-through revenue recognition method, the Company does not
recognize revenue upon shipment of product to the wholesaler. For these shipments, the Company
invoices the wholesaler, records deferred revenue at gross invoice sales price, and classifies the
inventory held by the wholesaler (and subsequently held by retail pharmacies as in the case of
AVINZA) as deferred cost of goods sold within other current assets. Deferred revenue is
presented net of deferred cash and other discounts. Other deferred revenue reflects certain
collaborative research and development payments and the sale of certain royalty rights.
The composition of deferred revenue, net is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Deferred product revenue |
|
$ |
153,604 |
|
|
$ |
153,632 |
|
Other deferred revenue |
|
|
5,451 |
|
|
|
5,574 |
|
Deferred discounts |
|
|
(1,326 |
) |
|
|
(2,166 |
) |
|
|
|
|
|
|
|
Deferred revenue, net |
|
$ |
157,729 |
|
|
$ |
157,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current, net |
|
$ |
153,372 |
|
|
$ |
152,528 |
|
|
|
|
|
|
|
|
Long term, net |
|
$ |
4,357 |
|
|
$ |
4,512 |
|
|
|
|
|
|
|
|
Deferred product revenue, net (1) |
|
|
|
|
|
|
|
|
Current |
|
$ |
152,278 |
|
|
$ |
151,466 |
|
|
|
|
|
|
|
|
Long term |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Other deferred revenue |
|
|
|
|
|
|
|
|
Current |
|
$ |
1,094 |
|
|
$ |
1,062 |
|
|
|
|
|
|
|
|
Long term |
|
$ |
4,357 |
|
|
$ |
4,512 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Deferred product revenue 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 consolidated financial statements. |
11
Accrued Liabilities. Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Allowances for loss on returns, rebates,
chargebacks, other discounts, ONTAK
end-customer and Panretin product returns |
|
$ |
18,219 |
|
|
$ |
16,151 |
|
Co-promotion |
|
|
6,966 |
|
|
|
7,845 |
|
Distribution services |
|
|
3,698 |
|
|
|
3,693 |
|
Compensation |
|
|
4,808 |
|
|
|
4,324 |
|
Royalties |
|
|
1,658 |
|
|
|
5,134 |
|
Seragen purchase liability |
|
|
2,838 |
|
|
|
2,838 |
|
Interest |
|
|
1,164 |
|
|
|
1,164 |
|
Other |
|
|
3,513 |
|
|
|
2,759 |
|
|
|
|
|
|
|
|
|
|
$ |
42,864 |
|
|
$ |
43,908 |
|
|
|
|
|
|
|
|
The following summarizes the activity in the accrued liability accounts related to allowances
for loss on returns, rebates, chargebacks, other discounts, ONTAK end-customer and Panretin product
returns:
|
|
|
|
|
|
|
|
|
|
|
June
30, 2005 |
|
|
June
30, 2004 |
|
|
|
|
|
|
|
(Restated) |
|
Balance beginning of period: |
|
$ |
16,151 |
|
|
$ |
9,196 |
|
|
|
|
|
|
|
|
|
|
Provision for ONTAK end-customer and Panretin returns |
|
|
1,405 |
|
|
|
1,152 |
|
Returns |
|
|
(1,908 |
) |
|
|
(1,148 |
) |
|
|
|
|
|
|
|
Net change ONTAK end-customer and Panretin returns |
|
|
(503 |
) |
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for losses on returns due to changes in prices |
|
|
4,330 |
|
|
|
3,027 |
|
Charges |
|
|
(2,643 |
) |
|
|
(1,815 |
) |
|
|
|
|
|
|
|
Net change losses on returns |
|
|
1,687 |
|
|
|
1,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for Medicaid rebates |
|
|
10,179 |
|
|
|
5,857 |
|
Payments |
|
|
(9,550 |
) |
|
|
(3,280 |
) |
|
|
|
|
|
|
|
Net change Medicaid rebates |
|
|
629 |
|
|
|
2,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for chargebacks |
|
|
2,540 |
|
|
|
1,759 |
|
Payments |
|
|
(2,943 |
) |
|
|
(1,594 |
) |
|
|
|
|
|
|
|
Net change chargebacks |
|
|
(403 |
) |
|
|
165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for managed care rebates and other contract discounts |
|
|
4,590 |
|
|
|
2,138 |
|
Payments |
|
|
(3,928 |
) |
|
|
(579 |
) |
|
|
|
|
|
|
|
Net change managed care rebates and other contract discounts |
|
|
662 |
|
|
|
1,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for other discounts |
|
|
|
|
|
|
4,966 |
|
Payments |
|
|
(4 |
) |
|
|
(3,747 |
) |
|
|
|
|
|
|
|
Net change other discounts |
|
|
(4 |
) |
|
|
1,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance end of period: |
|
$ |
18,219 |
|
|
$ |
15,932 |
|
|
|
|
|
|
|
|
12
Long-term Debt. Long-term debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
6% Convertible Subordinated Notes |
|
$ |
155,250 |
|
|
$ |
155,250 |
|
Note payable to bank |
|
|
12,000 |
|
|
|
12,159 |
|
|
|
|
|
|
|
|
|
|
|
167,250 |
|
|
|
167,409 |
|
Less current portion |
|
|
(331 |
) |
|
|
(320 |
) |
|
|
|
|
|
|
|
Long-term debt |
|
$ |
166,919 |
|
|
$ |
167,089 |
|
|
|
|
|
|
|
|
Condensed Changes in Stockholders Deficit. Condensed changes in stockholders deficit for the six
months ended June 30, 2005 are as follows (in thousands, except share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
Common stock |
|
|
Additional |
|
|
comprehensive |
|
|
Accumulated |
|
|
Treasury stock |
|
|
stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
paid-in capital |
|
|
income (loss) |
|
|
deficit |
|
|
Shares |
|
|
Amount |
|
|
(deficit) |
|
Balance at December 31, 2004 |
|
|
72,970,670 |
|
|
$ |
73 |
|
|
$ |
719,952 |
|
|
$ |
229 |
|
|
$ |
(794,660 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
(75,317 |
) |
Issuance of common stock |
|
|
163,045 |
|
|
|
|
|
|
|
972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
972 |
|
Unrealized loss on
available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(620 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(620 |
) |
Foreign currency
translation adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(29 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(27,396 |
) |
|
|
|
|
|
|
|
|
|
|
(27,396 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005 |
|
|
73,133,715 |
|
|
$ |
73 |
|
|
$ |
720,924 |
|
|
$ |
(420 |
) |
|
$ |
(822,056 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
(102,390 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 loss
(income) as a separate component of stockholders deficit. Comprehensive loss is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
2004 |
|
|
|
2005 |
|
|
(Restated) |
|
|
2005 |
|
|
(Restated) |
|
Net loss as reported |
|
$ |
(8,924 |
) |
|
$ |
(22,065 |
) |
|
$ |
(27,396 |
) |
|
$ |
(43,977 |
) |
Unrealized gain (loss) on available-for-sale
securities |
|
|
340 |
|
|
|
(62 |
) |
|
|
(620 |
) |
|
|
(54 |
) |
Foreign currency translation adjustments |
|
|
(22 |
) |
|
|
(12 |
) |
|
|
(29 |
) |
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(8,606 |
) |
|
$ |
(22,139 |
) |
|
$ |
(28,045 |
) |
|
$ |
(44,038 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The components of accumulated other comprehensive (loss) income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Net unrealized holding gain on
available-for-sale securities |
|
$ |
(321 |
) |
|
$ |
299 |
|
Net unrealized loss on foreign currency
translation |
|
|
(99 |
) |
|
|
(70 |
) |
|
|
|
|
|
|
|
|
|
$ |
(420 |
) |
|
$ |
229 |
|
|
|
|
|
|
|
|
13
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. 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, 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 our products and the expiration
of the underlying patents for each product is as follows:
|
|
|
|
|
|
|
|
|
|
|
Revenue Recognition |
|
Patent |
|
|
Method |
|
Event |
|
Expiration |
AVINZA
|
|
Sell-through
|
|
Prescriptions
|
|
November 2017 |
ONTAK
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
December 2014 |
Targretin capsules
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Targretin gel
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Panretin
|
|
Sell-in
|
|
Shipment to wholesaler
|
|
August 2016 |
International
|
|
Sell-in
|
|
Shipment to
international
distributor
|
|
February 2011
through April 2013 |
For the three months ended June 30, 2005 and 2004, net product sales recognized under the
sell-through method represented 96% and 97% of total net product sales and net product sales
recognized under the sell-in method represented 4% and 3%, respectively. For the six months ended
June 30, 2005 and 2004, net product sales recognized under the sell-through method represented 96%
of total net product sales and net product sales recognized under the sell-in method represented 4%
of total net product sales in 2005 and 2004.
The Companys total net product sales for the three months ended June 30, 2005 were $41.7
million compared to $29.3 million for the same 2004 period. Total net product sales for the six
months ended June 30, 2005 were $76.8 million compared to $54.2 million for the same 2004 period.
A comparison of sales by product is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
2004 |
|
|
|
2005 |
|
|
(Restated) |
|
|
2005 |
|
|
(Restated) |
|
AVINZA |
|
$ |
27,461 |
|
|
$ |
14,177 |
|
|
$ |
49,458 |
|
|
$ |
27,454 |
|
ONTAK |
|
|
8,779 |
|
|
|
9,966 |
|
|
|
16,803 |
|
|
|
17,277 |
|
Targretin capsules |
|
|
4,671 |
|
|
|
4,136 |
|
|
|
8,686 |
|
|
|
7,553 |
|
Targretin gel and Panretin gel |
|
|
824 |
|
|
|
1,020 |
|
|
|
1,833 |
|
|
|
1,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
41,735 |
|
|
$ |
29,299 |
|
|
$ |
76,780 |
|
|
$ |
54,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
14
The composition of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Collaborative research and development |
|
$ |
862 |
|
|
$ |
2,147 |
|
|
$ |
1,724 |
|
|
$ |
4,319 |
|
Development milestones and other |
|
|
3,202 |
|
|
|
828 |
|
|
|
4,280 |
|
|
|
1,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,064 |
|
|
$ |
2,975 |
|
|
$ |
6,004 |
|
|
$ |
5,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassifications. Certain reclassifications have been made to amounts included in the condensed
consolidated balance sheet as of December 31, 2004 to conform to the current year presentation.
2. Restatement of Previously Issued Consolidated Financial Statements
As described in the Companys Annual Report on Form 10-K for the year ended December 31, 2004,
the Company has restated its consolidated financial statements for the first three quarters of
2004. This Form 10-Q includes restated quarterly information for the three and six months ended
June 30, 2004.
Set forth below is a summary of the significant determinations regarding the restatement
addressed in the course of the restatement that affected the Companys consolidated financial
statements for the three and six months ended June 30, 2004.
Revenue Recognition. The restatement corrects the recognition of revenue for transactions
involving each of the Companys products that did not satisfy all of the conditions for revenue
recognition contained in SFAS 48 Revenue Recognition When Right of Return Exists (SFAS 48) and
Staff Accounting Bulletin (SAB) No. 101 -Revenue Recognition, as amended by SAB 104 (hereinafter
referred to as SAB 104). The Companys products impacted by this restatement are the domestic
product shipments of AVINZA, ONTAK, Targretin capsules, and Targretin gel. Management determined
that based upon SFAS 48 and SAB 104 it did not have the ability to make reasonable estimates of
future returns because there was (i) a lack of sufficient visibility into the wholesaler and retail
distribution channels; (ii) an absence of historical experience with similar products; (iii)
increasing levels of inventory in the wholesale and retail distribution channels as a result of
increasing demand of the Companys new products among other factors; and (iv) a concentration of a
few large distributors. As a result, the Company could not make reliable and reasonable estimates
of returns which precluded it from recognizing revenue at the time of product shipment, and
therefore such transactions were restated using the sell-through method. The restatement of
product revenue under the sell-through method required the correction of other accounts whose
balances were largely based upon the prior accounting policy. Such accounts include gross to net
sales adjustments and cost of goods (products) sold. Gross to net sales adjustments include
allowances for returns, rebates, chargebacks, discounts, and promotions, among others. Cost of
product sold includes manufacturing costs and royalties.
The restatement did not affect the revenue recognition of Panretin or the Companys
international product sales. For Panretin, the Companys wholesalers only stock minimal amounts of
product, if any. As such, wholesaler orders are considered to approximate end-customer demand for
the product. For international sales, the Companys products are sold to third-party distributors,
for which the Company has had minimal returns. For these sales, the Company believes that it has
met the SFAS 48 and SAB 104 criteria for recognizing revenue.
Specific models were developed for: AVINZA, including a separate model for each dosage
strength (a retail-stocked product for which the sell-through revenue recognition event is
prescriptions as reported by a third party data provider, IMS Health Incorporated, or IMS);
Targretin capsules and gel (for which revenue recognition is based on wholesaler out-movement as
reported by IMS); and ONTAK (for which revenue recognition is based on wholesaler out-movement as
reported to the Company by its wholesalers as the product is generally not stocked in pharmacies).
Separate models were also required for each of the adjustments associated with the gross to net
sales adjustments and cost of goods sold. The Company also developed separate demand
reconciliations for each product to assess the reasonableness of the third party information
described above.
15
Under the sell-through method used in the restatement and on a going-forward basis, 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 less estimated cash discounts and, for ONTAK, end-customer returns, and classifies the
inventory held by the wholesaler as deferred cost of goods sold within other current assets.
Additionally, for royalties paid to technology partners based on product shipments to wholesalers,
the Company records the cost of such royalties as deferred royalty expense within other current
assets. Royalties paid to technology partners are deferred as the Company has the right to offset
royalties paid for product later returned against subsequent royalty obligations. Royalties for
which the Company does not have the ability to offset (for example, at the end of the contracted
royalty period) are expensed in the period the royalty obligation becomes due. The Company
recognizes revenue when inventory is sold through (as discussed below), on a first-in first-out
(FIFO) basis. Sell-through for AVINZA is considered to be at the prescription level or at the time
of end user consumption for non-retail prescriptions. Thus, changes in wholesaler or retail
pharmacy inventories of AVINZA do not affect the Companys product revenues. Sell-through for
ONTAK, Targretin capsules, and Targretin gel is considered to be at the time the product moves from
the wholesaler to the wholesalers customer. Changes in wholesaler inventories for all the
Companys products, including product that the wholesaler returns to the Company for credit, do not
affect product revenues but will be reflected as a change in deferred product revenue.
The Companys revenue recognition is subject to the inherent limitations of estimates that
rely on third-party data, as certain-third party information is itself in the form of estimates.
Accordingly, the Companys sales and revenue recognition under the sell-through method reflect the
Companys estimates of actual product sold through the distribution channel. The estimates by
third parties include inventory levels and customer sell-through information the Company obtains
from wholesalers which currently account for a large percentage of the market demand for its
products. The Company also uses third-party market research data to make estimates where time lags
prevent the use of actual data. Certain third-party data and estimates are validated against the
Companys internal product movement information. To assess the reasonableness of third-party
demand (i.e. sell-through) information, the Company prepares separate demand reconciliations based
on inventory in the distribution channel. Differences identified through these demand
reconciliations outside an acceptable range are recognized as an adjustment to the third-party
reported demand in the period those differences are identified. This adjustment mechanism is
designed to identify and correct for any material variances between reported and actual demand over
time and other potential anomalies such as inventory shrinkage at wholesalers or retail pharmacies.
As a result of the Companys adoption of the sell-through method, it recognized deferred
revenue and a corresponding reduction to net product sales in the amount of $8.1 million and $17.3
million for the three and six months ended June 30, 2004, respectively. Revenue which has been
deferred will be recognized as the product sells through in future periods as discussed above.
Sale of Royalty Rights. In March 2002, the Company entered into an agreement with Royalty
Pharma AG (Royalty Pharma) to sell a portion of its rights to future royalties from the net sales
of three selective estrogen receptor modulator (SERM) products now in late stage development with
two of the Companys collaborative partners, Pfizer Inc. and American Home Products Corporation,
now known as Wyeth, in addition to the right, but not the obligation, to acquire additional
percentages of the SERM products net sales on future dates by giving the Company notice. When
the Company entered into the agreement with Royalty Pharma and upon each subsequent exercise of its
options to acquire additional percentages of royalty payments to the Company, the Company
recognized the consideration paid to it by Royalty Pharma as revenue.
The Company determined that a portion of the revenue recognized under the Royalty Pharma
agreement should have been deferred since Pfizer and Wyeth each had the right to offset a portion
of future royalty payments for, and to the extent of, amounts previously paid to the Company for
certain development milestones. As of June 30, 2004, approximately $1.2 million was recorded as
deferred revenue in connection with the offset rights by the Companys collaborative partners,
Pfizer and Wyeth. The amounts associated with the offset rights against future royalty payments
will be recognized as revenue upon receipt of future royalties from the respective partners or upon
determination that no such future royalties will be forthcoming. Additionally, the Company
determined to defer a portion of such revenue as it relates to the value of the options sold to
Royalty Pharma until Royalty Pharma exercised such options or upon the expiration of the options.
As of June 30, 2004, the value of outstanding options
16
recorded as deferred revenue was $0.2 million. This amount was subsequently recognized as
revenue in the fourth quarter of 2004 when the underlying options were cancelled in connection with
Royalty Pharmas purchase of an additional 1.625% royalty on future sales of the SERM products.
Buy-Out of Salk Royalty Obligation. In March 2004, the Company paid The Salk Institute $1.1
million in connection with the Companys exercise of an option to buy out milestone payments, other
payment-sharing obligations and royalty payments due on future sales of lasofoxifene, a product
under development by Pfizer, for the prevention of osteoporosis in postmenopausal women, for which
a new drug application (NDA) was expected to be filed in 2004. At the time of the Companys
exercise of its buyout right, the payment was accounted for as a prepaid royalty asset to be
amortized on a straight-line basis over the period for which the Company had a contractual right to
the lasofoxifene royalties. This payment was included in other assets on the Companys
consolidated balance sheet at June 30, 2004. Pfizer filed the NDA for lasofoxifene with the United
States Food and Drug Administration in the third quarter of 2004. Because the NDA had not been
filed at the time the Company exercised its buyout right, the Company determined in the course of
the restatement that the payment should have been expensed. Accordingly, the Company corrected
such error and recognized the Salk payment as development expense for the three months ended March
31, 2004.
Pfizer Settlement Agreement. In April 1996, the Company and Pfizer entered into a settlement
agreement with respect to a lawsuit filed in December 1994 by the Company against Pfizer. In
connection with a collaborative research agreement the Company entered into with Pfizer in 1991,
Pfizer purchased shares of the Companys common stock. Under the terms of the settlement
agreement, at the option of either the Company or Pfizer, milestone and royalty payments owed to
the Company can be satisfied by Pfizer by transferring to the Company shares of the Companys
common stock at an exchange ratio of $12.375 per share. At the time of the settlement, the Company
accounted for the prior issuance of common stock to Pfizer as equity on its consolidated balance
sheet.
In conjunction with the restatement, the remaining common stock issued and outstanding to
Pfizer following the settlement was reclassified as common stock subject to conditional
redemption (between liabilities and equity) in accordance with Emerging Issue Task Force Topic
D-98, Classification and Measurement of Redeemable Securities (EITF D-98), which was issued in
July 2001.
EITF D-98 requires the security to be classified outside of permanent equity if there is a
possibility of redemption of securities that is not solely within the control of the issuer. Since
Pfizer has the option to settle with Companys shares milestone and royalties payments owed to the
Company, the Company determined that such factors indicated that the redemptions were not within
the Companys control, and accordingly, EITF D-98 was applicable to the treatment of the common
stock issued to Pfizer. This adjustment totaling $14.6 million only had an effect on the balance
sheet classification, not on the consolidated statements of operations. In the third quarter of
2004, Pfizer elected to pay a $2.0 million milestone payment due the Company in stock and
subsequently tendered approximately 181,000 shares to the Company. The Company retired such shares
in September 2004 and common stock subject to conditional redemption was reduced by approximately
$2.3 million.
Seragen Litigation. On December 11, 2001, a lawsuit was filed in the United States District
Court for the District of Massachusetts against the Company by the Trustees of Boston University
and other former stakeholders of Seragen. The suit was subsequently transferred to federal
district court in Delaware. The complaint alleges breach of contract, breach of the implied
covenants of good faith and fair dealing and unfair and deceptive trade practices based on, among
other things, allegations that the Company wrongfully withheld approximately $2.1 million in
consideration due the plaintiffs under the Seragen acquisition agreement. This amount had been
previously accrued for in the Companys consolidated financial statements in 1998. The complaint
seeks payment of the withheld consideration and treble damages. The Company filed a motion to
dismiss the unfair and deceptive trade practices claim. The Court subsequently granted the
Companys motion to dismiss the unfair and deceptive trade practices claim (i.e. the treble damages
claim), in April 2003. In November 2003, the Court granted Boston Universitys motion for summary
judgment, and entered judgment for Boston University. In January 2004, the district court issued
an amended judgment awarding interest of approximately $0.7 million to the plaintiffs in addition
to the approximately $2.1 million withheld. The Court award of interest was previously not
accrued. Although the Company has appealed the judgment in this case as well as the award of
interest and the calculation of
17
damages, in view of the judgment, the Company revised its consolidated financial statements in
the fourth quarter of 2003 to record a charge of $0.7 million.
Other. In conjunction with the restatement, the Company also made other adjustments and
reclassifications to its accounting for various other errors, in various years, including, but not
limited to: (1) a correction to the Companys estimate of the accrual for clinical trials; (2)
corrections to estimates of other accrued liabilities; (3) royalty payments made to technology
partners; (4) straight-line recognition of rent expense for contractual annual rent increases; and
(5) corrections to estimates of future obligations and bonuses to employees.
The following tables reconcile the Companys consolidated financial position and results of
operations from the previously reported consolidated financial statements to the restated
consolidated financial statements at or for the three and six months ended June 30, 2004.
18
LIGAND PHARMACEUTICALS INCORPORATED
EFFECTS OF THE RESTATEMENT
(in thousands, except share and per share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the three |
|
|
For the six |
|
|
|
months ended |
|
|
months ended |
|
|
|
June 30, 2004 |
|
|
June 30, 2004 |
|
Net loss, as previously reported: |
|
$ |
(14,216 |
) |
|
$ |
(27,355 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to net loss (increase) decrease: |
|
|
|
|
|
|
|
|
Product sales: |
|
|
|
|
|
|
|
|
Net product sales (a) |
|
|
(8,097 |
) |
|
|
(17,342 |
) |
Other (b) |
|
|
(89 |
) |
|
|
(41 |
) |
Cost of products sold: |
|
|
|
|
|
|
|
|
Product cost (c) |
|
|
214 |
|
|
|
1,100 |
|
Royalties (c) |
|
|
(6 |
) |
|
|
386 |
|
Research and development: |
|
|
|
|
|
|
|
|
Reclassification (d) |
|
|
1,454 |
|
|
|
2,196 |
|
Salk-buyout (e) |
|
|
|
|
|
|
(1,120 |
) |
Patent expense (f) |
|
|
|
|
|
|
(238 |
) |
Other (b) |
|
|
154 |
|
|
|
105 |
|
Selling, general and administrative expenses: |
|
|
|
|
|
|
|
|
Reclassification (d) |
|
|
(1,454 |
) |
|
|
(2,196 |
) |
Legal expense (g) |
|
|
|
|
|
|
373 |
|
Other (b) |
|
|
(37 |
) |
|
|
99 |
|
Interest: |
|
|
|
|
|
|
|
|
Other (b) |
|
|
12 |
|
|
|
56 |
|
Other, net: |
|
|
|
|
|
|
|
|
Income taxes (h) |
|
|
18 |
|
|
|
34 |
|
Income tax expense (h) |
|
|
(18 |
) |
|
|
(34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, as restated |
|
$ |
(22,065 |
) |
|
$ |
(43,977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share Data |
|
|
|
|
|
|
|
|
As previously reported: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.19 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
73,754,146 |
|
|
|
73,528,581 |
|
|
|
|
|
|
|
|
As restated: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.30 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
73,754,146 |
|
|
|
73,528,581 |
|
|
|
|
|
|
|
|
Refer to the explanation of adjustments on the next page.
19
EFFECTS OF THE RESTATEMENT
The adjustments relate to the following:
|
|
|
(a) |
|
To reflect the change in the revenue recognition method from the sell-in method to the
sell-through method. |
|
(b) |
|
To reflect other adjustments and reclassifications. |
|
(c) |
|
To reflect the effect of the sell-through revenue recognition method on cost of
products sold and royalties. |
|
(d) |
|
To reclassify expenses incurred for the technology transfer and validation effort
related to the second source of supply for AVINZA from research and development expense to
selling, general and administrative expense. |
|
(e) |
|
To expense the payment to The Salk Institute to buy-out the Companys royalty
obligation on lasofoxifene in March 2004. |
|
(f) |
|
To correct patent expense. |
|
(g) |
|
To correct legal expense. |
|
(h) |
|
To reclassify income taxes related to international operations. |
20
LIGAND PHARMACEUTICALS INCORPORATED
EFFECTS OF THE RESTATEMENT
CONSOLIDATED BALANCE SHEET
(unaudited) (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2004 |
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
As |
|
|
Effect of |
|
|
Current |
|
|
|
|
|
|
Previously |
|
|
Prior Period |
|
|
Quarter |
|
|
As |
|
|
|
Reported |
|
|
Adjustments |
|
|
Adjustments |
|
|
Restated |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,920 |
|
|
|
|
|
|
|
|
|
|
$ |
41,920 |
|
Short-term investments |
|
|
43,958 |
|
|
|
|
|
|
|
|
|
|
|
43,958 |
|
Accounts receivable, net |
|
|
17,936 |
|
|
$ |
(113 |
) (a) |
|
$ |
(49 |
) (a) |
|
|
17,774 |
|
Inventories, net |
|
|
11,752 |
|
|
|
97 |
(a) |
|
|
118 |
(a) |
|
|
11,967 |
|
Other current assets |
|
|
3,245 |
|
|
|
13,824 |
(a)(b) |
|
|
(601 |
) (a)(b) |
|
|
16,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
118,811 |
|
|
|
13,808 |
|
|
|
(532 |
) |
|
|
132,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted investments |
|
|
1,656 |
|
|
|
|
|
|
|
|
|
|
|
1,656 |
|
Property and equipment, net |
|
|
23,910 |
|
|
|
|
|
|
|
|
|
|
|
23,910 |
|
Acquired technology and product rights, net |
|
|
132,520 |
|
|
|
260 |
(a)(c) |
|
|
|
|
|
|
132,780 |
|
Other assets |
|
|
8,420 |
|
|
|
(1,208 |
) (a)(d) |
|
|
|
|
|
|
7,212 |
|
|
|
|
|
|
$ |
285,317 |
|
|
$ |
12,860 |
|
|
$ |
(532 |
) |
|
$ |
297,645 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
20,225 |
|
|
$ |
1 |
(a) |
|
$ |
|
|
|
$ |
20,226 |
|
Accrued liabilities |
|
|
36,108 |
|
|
|
66 |
(a)(e) |
|
|
(364 |
) (a)(e) |
|
|
35,810 |
|
Current portion of deferred revenue, net |
|
|
2,381 |
|
|
|
113,812 |
(f) |
|
|
7,661 |
(f) |
|
|
123,854 |
|
Current portion of equipment financing obligations |
|
|
2,453 |
|
|
|
|
|
|
|
|
|
|
|
2,453 |
|
Current portion of long-term debt |
|
|
303 |
|
|
|
|
|
|
|
|
|
|
|
303 |
|
|
|
|
Total current liabilities |
|
|
61,470 |
|
|
|
113,879 |
|
|
|
7,297 |
|
|
|
182,646 |
|
Long-term debt |
|
|
167,256 |
|
|
|
|
|
|
|
|
|
|
|
167,256 |
|
Long-term portion of deferred revenue, net |
|
|
2,120 |
|
|
|
1,173 |
(g) |
|
|
|
|
|
|
3,293 |
|
Long-term portion of equipment financing obligations |
|
|
3,547 |
|
|
|
|
|
|
|
|
|
|
|
3,547 |
|
Other long-term liabilities |
|
|
2,925 |
|
|
|
268 |
(h) |
|
|
20 |
(h) |
|
|
3,213 |
|
|
|
|
Total liabilities |
|
|
237,318 |
|
|
|
115,320 |
|
|
|
7,317 |
|
|
|
359,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock subject to conditional redemption |
|
|
|
|
|
|
14,595 |
(i) |
|
|
|
|
|
|
14,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity (deficit): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock |
|
|
74 |
|
|
|
(1 |
) (i) |
|
|
|
|
|
|
73 |
|
Additional paid-in capital |
|
|
732,096 |
|
|
|
(14,540 |
) (a)(i) |
|
|
|
|
|
|
717,556 |
|
Accumulated other comprehensive loss |
|
|
(127 |
) |
|
|
|
|
|
|
|
|
|
|
(127 |
) |
Accumulated deficit |
|
|
(683,133 |
) |
|
|
(102,514 |
) |
|
|
(7,849 |
) |
|
|
(793,496 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,910 |
|
|
|
(117,055 |
) |
|
|
(7,849 |
) |
|
|
(75,994 |
) |
Treasury stock |
|
|
(911 |
) |
|
|
|
|
|
|
|
|
|
|
(911 |
) |
|
|
|
Total stockholders equity (deficit): |
|
|
47,999 |
|
|
|
(117,055 |
) |
|
|
(7,849 |
) |
|
|
(76,905 |
) |
|
|
|
|
|
|
$ |
285,317 |
|
|
$ |
12,860 |
|
|
$ |
(532 |
) |
|
$ |
297,645 |
|
|
|
|
Refer to the explanation of adjustments on the next page.
21
EFFECTS OF THE RESTATEMENT
The adjustments relate to the following (in thousands):
|
|
|
(a) |
|
To reflect other adjustments and reclassifications. |
|
(b) |
|
Cumulative effect of prior period adjustments includes $14,057 related to the change to
the sell-through revenue recognition method (deferred royalties $9,580; deferred cost of
products sold $4,477). Current quarter adjustments include $(781) related to the change
to the sell-through revenue recognition method (deferred royalties $(876); deferred cost
of products sold $95). |
|
(c) |
|
To correct accumulated amortization expense related to ONTAK acquired technology
$357. |
|
(d) |
|
To expense the effect of The Salk Institute payment to buy-out the Companys royalty
obligation on lasofoxifene $(1,120). |
|
(e) |
|
Cumulative effect of prior period adjustments includes $(2,698) related to the change
to the sell-through revenue recognition method (product cost $(3,162); royalties $464);
to correct property tax expense $(260); to reclassify Seragen acquisition liability from
other long-term liabilities $2,100; accrual of interest on the Seragen acquisition
liability $739. Current quarter adjustments include $(358) related to the change to the
sell-through revenue recognition method (product cost $510; royalties $(868)). |
|
(f) |
|
To reflect the change in the revenue recognition method from the sell-in method to the
sell-through method. |
|
(g) |
|
To reflect the deferral of a portion of the sales of royalty rights to Royalty Pharma. |
|
(h) |
|
The cumulative effect of prior period adjustments reflects the effect of the adjustment
to rent expense for contractual annual rent increases recognized over the lease term on a
straight line basis $2,368; to reclassify the Seragen acquisition liability to accrued
liabilities $(2,100). Current quarter adjustment reflects the adjustment to rent expense
for contractual annual rent increase recognized over the lease term on a straight line
basis $20. |
|
(i) |
|
To reclassify from equity the Companys issuance of common stock subject to conditional
redemption to Pfizer, in connection with the Pfizer settlement agreement in accordance with
EITF D-98 $(14,595) common stock $(1), additional paid-in capital $(14,594). |
22
LIGAND PHARMACEUTICALS INCORPORATED
EFFECTS OF THE RESTATEMENT
CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2004 |
|
|
|
As |
|
|
|
|
|
|
|
|
|
|
Previously |
|
|
|
|
|
|
As |
|
|
|
Reported |
|
|
Adjustments |
|
|
Restated |
|
|
|
|
Product sales |
|
$ |
37,485 |
|
|
$ |
(8,186 |
) (a)(b) |
|
$ |
29,299 |
|
Collaborative research and development
and other revenues |
|
|
2,975 |
|
|
|
|
|
|
|
2,975 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
40,460 |
|
|
|
(8,186 |
) |
|
|
32,274 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
9,926 |
|
|
|
(208 |
) (c) |
|
|
9,718 |
|
Research and development |
|
|
18,174 |
|
|
|
(1,608 |
) (b)(d) |
|
|
16,566 |
|
Selling, general and administrative |
|
|
16,625 |
|
|
|
1,491 |
(b)(d) |
|
|
18,116 |
|
Co-promotion |
|
|
7,000 |
|
|
|
|
|
|
|
7,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
51,725 |
|
|
|
(325 |
) |
|
|
51,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(11,265 |
) |
|
|
(7,861 |
) |
|
|
(19,126 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
208 |
|
|
|
|
|
|
|
208 |
|
Interest expense |
|
|
(3,140 |
) |
|
|
12 |
(b) |
|
|
(3,128 |
) |
Other, net |
|
|
(19 |
) |
|
|
18 |
(e) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expense, net |
|
|
(2,951 |
) |
|
|
30 |
|
|
|
(2,921 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(14,216 |
) |
|
|
(7,831 |
) |
|
|
(22,047 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
|
|
|
|
(18 |
) (e) |
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(14,216 |
) |
|
$ |
(7,849 |
) |
|
$ |
(22,065 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(0.19 |
) |
|
|
|
|
|
$ |
(0.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
73,754,146 |
|
|
|
|
|
|
|
73,754,146 |
|
|
|
|
|
|
|
|
|
|
|
|
Refer to the explanation of adjustments on the next page.
23
EFFECTS OF THE RESTATEMENT
The adjustments relate to the following (in thousands):
|
|
|
(a) |
|
To reflect the change in the revenue recognition method from the sell-in method to the
sell-through method net product sales $(8,097). |
|
(b) |
|
To reflect other adjustments and reclassifications. |
|
(c) |
|
To reflect the effect of the sell-through revenue recognition method on cost of
products sold and royalties product sales $(214); royalties $6. |
|
(d) |
|
To reclassify $1,454 of expenses incurred for the technology transfer and validation
effort related to the second source of supply for AVINZA from research and development
expense to selling, general and administrative expense. |
|
(e) |
|
To reclassify income taxes related to international operations $18. |
24
EFFECTS OF THE RESTATEMENT FOR THE SIX MONTHS ENDED JUNE 30, 2004
CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2004 |
|
|
|
As |
|
|
|
|
|
|
|
|
|
|
Previously |
|
|
|
|
|
|
As |
|
|
|
Reported |
|
|
Adjustments |
|
|
Restated |
|
|
|
|
Product sales |
|
$ |
71,621 |
|
|
$ |
(17,383 |
) (a)(b) |
|
$ |
54,238 |
|
Collaborative research and development and other revenues |
|
|
5,451 |
|
|
|
|
|
|
|
5,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
77,072 |
|
|
|
(17,383 |
) |
|
|
59,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
18,749 |
|
|
|
(1,486 |
) (c) |
|
|
17,263 |
|
Research and development |
|
|
35,026 |
|
|
|
(943 |
) (b)(d)(e)(f) |
|
|
34,083 |
|
Selling, general and administrative |
|
|
31,097 |
|
|
|
1,724 |
(b)(d)(g) |
|
|
32,821 |
|
Co-promotion |
|
|
13,731 |
|
|
|
|
|
|
|
13,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
98,603 |
|
|
|
(705 |
) |
|
|
97,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(21,531 |
) |
|
|
(16,678 |
) |
|
|
(38,209 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
439 |
|
|
|
|
|
|
|
439 |
|
Interest expense |
|
|
(6,231 |
) |
|
|
56 |
(b) |
|
|
(6,175 |
) |
Other, net |
|
|
(32 |
) |
|
|
34 |
(h) |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expense, net |
|
|
(5,824 |
) |
|
|
90 |
|
|
|
(5,734 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
$ |
(27,355 |
) |
|
$ |
(16,588 |
) |
|
$ |
(43,943 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
|
|
|
|
(34 |
) (h) |
|
|
(34 |
) |
|
|
|
Net loss |
|
$ |
(27,355 |
) |
|
$ |
(16,622 |
) |
|
$ |
(43,977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(0.37 |
) |
|
|
|
|
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
73,528,581 |
|
|
|
|
|
|
|
73,528,581 |
|
|
|
|
|
|
|
|
|
|
|
|
Refer to the explanation of adjustments on the next page
25
EFFECTS OF THE RESTATEMENT
The adjustments relate to the following (in thousands):
|
|
|
(a) |
|
To reflect the change in the revenue recognition method from the sell-in method to the
sell-through method net product sales $(17,342). |
|
(b) |
|
To reflect other adjustments and reclassifications. |
|
(c) |
|
To reflect the effect of the sell-through revenue recognition method on cost of
products sold and royalties product sales $(1,100); royalties $(386). |
|
(d) |
|
To reclassify $2,196 of expenses incurred for the technology transfer and validation
effort related to the second source of supply for AVINZA from research and development
expense to selling, general and administrative expense. |
|
(e) |
|
To expense the payment to The Salk Institute to buy-out the Companys royalty
obligation on lasofoxifene in March 2004 $1,120. |
|
(f) |
|
To correct patent expense $238. |
|
(g) |
|
To reflect legal expense in the proper accounting period $(373). |
|
(h) |
|
To reclassify income taxes related to international operations $34. |
26
3. 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 again 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, 2005 and 2004 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.
The agreement requires the Company to provide its consolidated financial statements to the
finance company within 120 days after year-end. Because the Company was unable to complete its
restated consolidated financial statements within 120 days, it was in default of this requirement.
A waiver of this financial reporting covenant, however, has been granted through December 31, 2005.
The Company subsequently completed its restated consolidated financial statements and provided
such financial statements to the finance company in November 2005.
As of June 30, 2005 and December 31, 2004, the Company had received cash of $16.4 million and
$17.2 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, 2005
and December 31, 2004 was $19.7 million and $6.1 million, respectively.
4. 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, exercisable in January 2005 and April 2005, 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 exercised one or both of its options.
Ligands first option, providing for a one-time payment of $20.0 million to Lilly in exchange
for the elimination of Ligands ONTAK royalty obligations in 2005 and a reduced reverse-tiered
royalty scale on ONTAK sales in the U.S. thereafter, was exercised and paid in January 2005. The
second option which provides 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 and paid 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 would 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.
As of June 30, 2005, 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 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.
27
Salk Payment
In January 2005, Ligand paid The Salk Institute $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 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 The Salk Institute, approximately $0.6 million, as
development expense in the first quarter of 2005. The balance of approximately $0.5 million was
capitalized and will be amortized over the period any such royalties are received from Pfizer for
the vaginal atrophy indication.
Settlement of Patent Interference
In March 2005, Ligand announced that it reached a settlement agreement in a recent 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 will have 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 will be 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.
5. Targretin Capsules
In March 2005, the Company announced that the final data analysis for Targretin capsules in
non-small cell lung cancer (NSCLC) showed that the trials did not meet their endpoints of improved
overall survival and projected two year survival. The Company is continuing to analyze the data
and apply it to the continued development of Targretin capsules in NSCLC.
6. 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
is structured as a percentage of net sales based on Ligands standard accounting principles and
generally accepted accounting principles (GAAP), which pays Organon for their efforts and also
provides Organon an economic incentive for performance and results. In exchange, Ligand pays
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% |
$150-300 million |
|
40% |
$300-425 million |
|
50% |
> $425 million |
|
45% |
Through the announcement of the restatement, Ligand calculated and paid Organons compensation
according to its prior application of GAAP and its prior standard accounting principles. The
restatement corrects the recognition of revenue for transactions involving AVINZA that did not
satisfy all of the conditions for revenue recognition contained in SFAS 48 and SAB 104. Shipments made to wholesalers for AVINZA did
not meet the revenue
28
recognition criteria under GAAP and such transactions were restated using the
sell-through method as opposed to the sell-in method previously used.
Under the sell-through method, Ligand does not recognize revenue upon shipment of AVINZA to
the wholesaler. As a result, Ligand believes it has overpaid Organon under the terms of the
agreement by approximately $11.5 million through June 30, 2005. Ligand has notified Organon
regarding the overpayment and its intention to apply such overpayment to future amounts due under
the co-promotion agreement calculated under GAAP and its standard accounting principles. Organon
has expressed its disagreement with this position and Ligand is currently in discussions with
Organon. While the discussions continue, the payments made and under discussion are reflected in
Ligands consolidated financial statements as co-promotion expense. Therefore, the consolidated
financial statements included herein do not recognize the overpayment pending resolution of the
matter. Until this matter is resolved, Ligand will continue to account for co-promotion expense
based on net sales determined using the sell-in method.
7. Litigation
Seragen, Inc., our subsidiary, 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 our acquisition
subsidiary, Knight Acquisition Corporation, were dismissed from the action. Claims of breach of
fiduciary duty remain against the remaining defendants, including the former officers and directors
of Seragen. The hearing on the plaintiffs motion for class certification took place on February
26, 2001. 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. The Court denied plaintiffs motion for summary judgment in its entirety. Trial
was scheduled for February 7, 2005. 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. The timing of a decision by the Court and
the outcome are unknown. While Ligand and its subsidiary Seragen have been dismissed from the
action, such dismissal is subject to a possible subsequent appeal upon any judgment in the action
against the remaining parties, as well as possible indemnification obligations with respect to
certain defendants.
On December 11, 2001, a lawsuit was filed in the United States District Court for the District
of Massachusetts against Ligand by the Trustees of Boston University and other former stakeholders
of Seragen. The suit was subsequently transferred to federal district court in Delaware. The
complaint alleges breach of contract, breach of the implied covenants of good faith and fair
dealing and unfair and deceptive trade practices based on, among other things, allegations that
Ligand wrongfully withheld approximately $2.1 million in consideration due the plaintiffs under the
Seragen acquisition agreement. This amount had been previously accrued for in the Companys
consolidated financial statements in 1998. The complaint seeks payment of the withheld
consideration and treble damages. Ligand filed a motion to dismiss the unfair and deceptive trade
practices claim. The Court subsequently granted Ligands motion to dismiss the unfair and
deceptive trade practices claim (i.e. the treble damages claim), in April 2003. In November 2003,
the Court granted Boston Universitys motion for summary judgment, and entered judgment for Boston
University. In January 2004, the district court issued an amended judgment awarding interest of
approximately $0.7 million to the plaintiffs in addition to the approximately $2.1 million
withheld. In view of the judgment, the Company recorded a charge of $0.7 million to Selling,
general and administrative expense in the fourth quarter of 2003. The Company continues to
believe that the plaintiffs claims are without merit and has appealed the judgment in this case as
well as the award of interest and the
calculation of damages. The appeal has been fully briefed and was argued in June 2005 and the
parties are awaiting the courts decision. The likelihood of success on appeal is unknown.
29
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 on 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. No trial date has been set.
Beginning on or about August 13, 2004, several derivative actions were filed on behalf of the
Company by individual stockholders in the Superior Court of California. The complaints name the
Companys directors and certain of its officers as defendants and name the Company as a nominal
defendant. The complaints are based on the same facts and circumstances as the purported class
actions discussed in the previous paragraph and generally allege breach of fiduciary duties, abuse
of control, waste and mismanagement, insider trading and unjust enrichment. These actions are in
discovery. The court has set a trial date of May 26, 2006.
In October 2005, a shareholder derivative action was filed on behalf of the Company in the
United States District Court for the Southern District of California. The complaint names the
Companys directors and certain of its officers as defendants and the Company as a nominal
defendant. The action was brought by an individual stockholder. The complaint generally alleges
that the defendants falsified Ligands publicly reported financial results throughout 2002 and 2003
and the first three quarters of 2004 by improperly recognizing revenue on product sales. The
complaint generally alleges breach of fiduciary duty by all defendants and requests disgorgement,
e.g., under Section 304 of the Sarbanes-Oxley Act of 2002. No trial date has been set.
The Company believes that all of the above actions are without merit and intends to vigorously
defend against each of such lawsuits. Due to the uncertainty of the ultimate outcome of these
matters, the impact on future financial results is not subject to reasonable estimates.
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 requested the
Court to set a time and place and record date for such annual meeting and establish the quorum for
such meeting as the shares present at the meeting, notwithstanding any relevant provisions of
Ligands certificate of incorporation or bylaws. 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. The record date for the meeting is December 15, 2005. On
December 2, 2005, Ligand and Third Point also entered into a stockholders agreement under which,
among other things, Ligand will 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, with some conditions. Third Point will not sell its Ligand shares,
solicit proxies or take certain other stockholder actions for a minimum of six months and as long
as its designees remain on the board.
In connection with the restatement, the SEC instituted a formal investigation concerning the
Companys consolidated financial statements. These matters were previously the subject of an
informal SEC inquiry.
In addition, the Company is subject to various lawsuits and claims with respect to matters
arising out of the normal course of business. Due to the uncertainty of the ultimate outcome of
these matters, the impact on future financial results is not subject to reasonable estimates.
30
8. Purchase of Nexus Equity VI LLC
As of March 31, 2004, the Company leased one of its corporate office buildings from Nexus
Equity VI LLC (Nexus), a limited liability company in which Ligand held a 1% ownership interest.
Nexus had been first consolidated as of December 31, 2003 by the Company in accordance with FASB
Interpretation No. 46(R), Consolidation of Variable Interest Entities, an interpretation of
Accounting Research Bulletin No. 51.
In April 2004, the Company exercised its right to acquire the portion of Nexus that it did not
own. The acquisition resulted in Ligands assumption of the existing loan against the property and
payment to Nexus other shareholder of approximately $0.6 million.
9. New Accounting Pronouncements
In March 2004, the Financial Accounting Standards Board (FASB) approved the
consensus reached on the Emerging Issues Task Force (EITF) Issue No. 03-1, The Meaning of
Other-Than-Temporary Impairment and Its Application to Certain Investments (EITF 03-1). EITF 03-1
provides guidance for identifying impaired investments and new disclosure requirements for
investments that are deemed to be temporarily impaired. In September 2004, the FASB delayed the
accounting provisions of EITF 03-1; however the disclosure requirements remain effective for annual
periods ending after June 15, 2004. The Company does not believe the impact of adopting EITF 03-1
will be significant to its overall results of operations or financial position.
In December 2004, the FASB issued SFAS No. 123R (revised 2004), Share-Based Payment (SFAS
123R). SFAS 123R replaced SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123), and
superseded Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees
(APB 25). In March 2005, the U.S. Securities and Exchange Commission (SEC) issued Staff
Accounting Bulletin No. 107 (SAB 107), which expresses views of the SEC staff regarding the
interaction between SFAS 123R and certain SEC rules and regulations, and provides the staffs views
regarding the valuation of share-based payment arrangements for public companies. SFAS 123R will
require compensation cost related to share-based payment transactions to be recognized in the
financial statements. SFAS 123R required public companies to apply SFAS 123R in the first interim
or annual reporting period beginning after June 15, 2005. In April 2005, the SEC approved a new
rule that delays the effective date, requiring public companies to apply SFAS 123R in their next
fiscal year, instead of the next interim reporting period, beginning after June 15, 2005. As
permitted by SFAS 123, the Company elected to follow the guidance of APB 25, which allowed
companies to use the intrinsic value method of accounting to value their share-based payment
transactions with employees. SFAS 123R requires measurement of the cost of share-based payment
transactions to employees at the fair value of the award on the grant date and recognition of
expense over the requisite service or vesting period. SFAS 123R requires implementation using a
modified version of prospective application, under which compensation expense of the unvested
portion of previously granted awards and all new awards will be recognized on or after the date of
adoption. SFAS 123R also allows companies to adopt SFAS 123R by restating previously issued
statements, basing the amounts on the expense previously calculated and reported in their pro forma
footnote disclosures required under SFAS 123. The Company will adopt SFAS 123R in the first
interim period of fiscal 2006 and is currently evaluating the impact that the adoption of SFAS 123R
will have on its results of operations and financial position.
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 impact of the adoption of SFAS No.
151 is not expected to have a material impact on the Companys consolidated statements of
operations or consolidated balance sheets.
In December 2004, the FASB issued SFAS No. 153, Exchanges of Nonmonetary Assets, to address
the measurement of exchanges of nonmonetary assets. It eliminates the exception from fair value
measurement for nonmonetary exchanges of similar productive assets in APB Opinion No. 29,
Accounting for Nonmonetary
31
Transactions, and replaces it with an exception for nonmonetary
exchanges that do not have commercial substance. This statement specifies that a nonmonetary
exchange has commercial substance if the future cash flows of the entity are expected to change
significantly as a result of the exchange. This statement is effective for nonmonetary asset
exchanges occurring in fiscal periods beginning after June 15, 2005. The impact of the adoption of
SFAS No. 153 is not expected to have a material impact on the Companys consolidated statements of
operations or consolidated balance sheets.
In May 2005, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 154,
Accounting Changes and Error Corrections (SFAS 154). SFAS 154 requires retrospective application
to prior-period financial statements of changes in accounting principles, unless it is
impracticable to determine either the period-specific effects or the cumulative effect of the
change. SFAS 154 also redefines restatement as the revising of previously issued financial
statements to reflect the correction of an error. This statement is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005.
10. Commitment
As of March 31, 2005, the Company entered into a consulting agreement with Dr. Ronald Evans, a
Salk professor and Howard Hughes Medical Institute investigator, that continues through February
2008. The agreement provides for certain cash payments and a grant of stock options. Dr. Evans
serves as a Chairman of Ligands Scientific Advisory Board.
11. Subsequent Events
NASDAQ Delisting
The Companys common stock was delisted from the NASDAQ National Market on September 7, 2005.
Unless and until the Companys common stock is relisted on NASDAQ, its common stock is expected to
be quoted on the Pink Sheets. The quotation of the Companys common stock on the Pink Sheets may
reduce the price of the common stock and the levels of liquidity available to the Companys
stockholders. In addition, the quotation of the Companys common stock on the Pink Sheets may
materially adversely affect the Companys access to the capital markets, and the limited liquidity
and reduced price of its common stock could materially adversely affect the Companys ability to
raise capital through alternative financing sources on terms acceptable to the Company or at all.
Stocks that are quoted on the Pink Sheets are no longer eligible for margin loans, and a company
quoted on the Pink Sheets cannot avail itself of federal preemption of state securities or blue
sky laws, which adds substantial compliance costs to securities issuances, including pursuant to
employee option plans, stock purchase plans and private or public offerings of securities. The
Companys delisting from the NASDAQ National Market and quotation on the Pink Sheets may also
result in other negative implications, including the potential loss of confidence by suppliers,
customers and employees, the loss of institutional investor interest and fewer business development
opportunities.
Pfizer Collaboration Lasofoxifene
In August 2004, Pfizer submitted an NDA to the FDA for lasofoxifene for the prevention of
osteoporosis in postmenopausal women. In September 2005, Pfizer announced the receipt of a
non-approvable letter from the FDA for the prevention of osteoporosis. In December 2004, Pfizer
filed a supplemental NDA for the use of lasofoxifene for the treatment of vaginal atrophy which
remains pending at the FDA. Lasofoxifene is also being developed by Pfizer for the treatment of
osteoporosis. Lasofoxifene is a product that resulted from the Companys collaboration with Pfizer
and upon which the Company will receive royalties if the product is approved by the FDA and
subsequently marketed by Pfizer.
Bylaws Amendment
On November 8, 2005, the Board of Directors of the Company approved an amendment to the
Companys Bylaws clarifying the Companys advance notice requirement for a stockholder who wishes
to bring business before an annual meeting of stockholders. The amended bylaw provides that, in
the event the annual meeting date has been
32
changed by more than 30 days from the date contemplated
in the previous years proxy statement, stockholder proposals for the annual meeting must be
received no later than 20 days after the earlier of the date on which (i) notice of the date of the
annual meeting was mailed to stockholders or (ii) public disclosure of the date of the meeting was
made to stockholders. Previously the bylaws stated that the time for receipt of such proposals was
a reasonable time before the solicitation is made.
Amended and Restated Research, Development and License Agreement with Wyeth
On December 1, 2005, the Company entered into an Amended and Restated Research, Development
and License Agreement with Wyeth (formerly American Home Products Corporation). Under the previous
agreement, effective September 2, 1994 as amended January 16, 1996, May 24, 1996, September 2, 1997
and September 9, 1999 (collectively the Prior Agreement), Wyeth and the Company engaged in a
joint research and development effort to discover and/or design small molecule compounds which act
through the estrogen and progesterone receptors and to develop pharmaceutical products from such
compounds. Wyeth sponsored certain research and development activities to be carried out by the
Company and Wyeth may commercialize products resulting from the joint research and development
subject to certain milestone and royalty payments. The Amended and Restated Agreement does not
materially change the prior rights and obligations of the parties with respect to Wyeth compounds,
currently in development, e.g. bazedoxifene, in late stage development for osteoporosis.
The parties agreed to amend and restate the Prior Agreement principally to better define,
simplify and clarify the universe of research compounds resulting from the research and development
efforts of the parties, combine and clarify categories of those compounds and related milestones
and royalties and resolve a number of milestone payment issues that had arisen. Among other
things, the Amended and Restated Agreement calls for Wyeth to pay Ligand $1.8 million representing
the difference between amounts paid under the old compound categories versus the amounts due under
the new, single category.
Stockholders Agreement
On December 2, 2005, the Company and Third Point Offshore Fund, Ltd. (Third Point) entered
into a stockholders agreement under which, among other things, the Company will expand its board
from eight to eleven, elect three designees of Third Point to the new board and pay certain of
Third Points expenses, not to exceed approximately $0.5 million, with some conditions. Third
Point will not sell its Ligand shares, solicit proxies or take certain other stockholders actions
for a minimum of six months and as long as its designees remain on the board. See Note 7.
Litigation.
33
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 under Part II, Item 1A. Risk Factors below. This outlook represents our current judgment
on the future direction of our business. These statements include those related to managements
trend analyses and expectations, Organon discussions; product and corporate partner pipeline;
litigation, the annual stockholders meeting, the SEC enforcement investigation, compliance with
the NASDAQ Listing Qualifications Panel requirements and the potential relisting of the Companys
securities, and material weaknesses and remediation. Actual events or results may differ
materially from Ligands expectations. For example, there can be no assurance that the Companys
subsequent processes and initiatives such as compliance with NASDAQ Listing Qualifications Panel
requirements will be completed or when, that the Company will achieve relisting by the NASDAQ Stock
Market and if so, when relisting will occur, that the Companys currently ongoing or future
litigation (including private litigation and the SEC investigation) will not have an adverse effect
on the Company, that the Company will be able to successfully conclude discussions with Organon,
that corporate or partner pipeline products will gain approval or success in the market, that the
Company will remediate any identified material weaknesses, that the sell-through revenue
recognition models will not require adjustment and not result in a subsequent restatement. In
addition, the Companys financial results and stock price may suffer as a result of the previously
announced restatement and delisting action by NASDAQ or as a result of any failure to remediate
material weaknesses and its relationships with its vendors, stockholders or other creditors may
suffer. Such risks and uncertainties could cause actual results to differ materially from any
future performance suggested. We undertake no obligation to release publicly the results of any
revisions to these forward-looking statements to reflect events or circumstances arising after the
date of this quarterly report. This caution is made under the safe harbor provisions of Section
21E of the Securities Exchange Act of 1934 as amended.
Our trademarks, trade names and service marks referenced herein include Ligand
Ò, AVINZA Ò , ONTAK Ò ,
Panretin Ò and Targretin Ò . Each other
trademark, trade name or service mark appearing in this quarterly report belongs to its owner.
References to Ligand Pharmaceuticals Incorporated (Ligand, the Company, we or our)
include our wholly owned subsidiaries Ligand Pharmaceuticals (Canada) Incorporated; Ligand
Pharmaceuticals International, Inc.; Seragen, Inc. (Seragen); and Nexus Equity VI LLC (Nexus).
Restatement of Previously Issued Consolidated Financial Statements
As described in our Annual Report on Form 10-K for the year ended December 31, 2004, we have
restated our consolidated financial statements for the first three quarters of 2004. This Form
10-Q includes restated quarterly information for the three and six months ended June 30, 2004. As
described in Note 2 to the consolidated financial statements in this Form 10-Q, the restatement
corrects our revenue recognition method of our domestic product shipments of AVINZA, ONTAK,
Targretin capsules and Targretin gel under SFAS 48 Revenue Recognition When Right of Return
Exists (SFAS 48) and Staff Accounting Bulletin (SAB) No. 101 Revenue Recognition, as
amended by SAB 104. Additionally, the restatement reflects adjustments in connection with the
buy-out of the Salk royalty obligation, the Pfizer settlement agreement, and other adjustments and
reclassifications relating to other accrued liabilities, including the estimates of future
obligations and bonuses to employees, and royalty payments made to technology partners.
The following table presents the restatement adjustments for the three and six months ended
June 30, 2004.
34
LIGAND PHARMACEUTICALS INCORPORATED
EFFECTS OF THE RESTATEMENT
(in thousands, except share and per share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the three |
|
|
For the six |
|
|
|
months ended |
|
|
months ended |
|
|
|
June 30, 2004 |
|
|
June 30, 2004 |
|
Net loss, as previously reported: |
|
$ |
(14,216 |
) |
|
$ |
(27,355 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to net loss (increase) decrease: |
|
|
|
|
|
|
|
|
Product sales: |
|
|
|
|
|
|
|
|
Net product sales (a) |
|
|
(8,097 |
) |
|
|
(17,342 |
) |
Other (b) |
|
|
(89 |
) |
|
|
(41 |
) |
Cost of products sold: |
|
|
|
|
|
|
|
|
Product cost (c) |
|
|
214 |
|
|
|
1,100 |
|
Royalties (c) |
|
|
(6 |
) |
|
|
386 |
|
Research and development: |
|
|
|
|
|
|
|
|
Reclassification (d) |
|
|
1,454 |
|
|
|
2,196 |
|
Salk-buyout (e) |
|
|
|
|
|
|
(1,120 |
) |
Patent expense (f) |
|
|
|
|
|
|
(238 |
) |
Other (b) |
|
|
154 |
|
|
|
105 |
|
Selling, general and administrative expenses: |
|
|
|
|
|
|
|
|
Reclassification (d) |
|
|
(1,454 |
) |
|
|
(2,196 |
) |
Legal expense (g) |
|
|
|
|
|
|
373 |
|
Other (b) |
|
|
(37 |
) |
|
|
99 |
|
Interest: |
|
|
|
|
|
|
|
|
Other (b) |
|
|
12 |
|
|
|
56 |
|
Other, net: |
|
|
|
|
|
|
|
|
Income taxes (h) |
|
|
18 |
|
|
|
34 |
|
Income tax expense (h) |
|
|
(18 |
) |
|
|
(34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, as restated |
|
$ |
(22,065 |
) |
|
$ |
(43,977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share Data |
|
|
|
|
|
|
|
|
As previously reported: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.19 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
73,754,146 |
|
|
|
73,528,581 |
|
|
|
|
|
|
|
|
As restated: |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.30 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
73,754,146 |
|
|
|
73,528,581 |
|
|
|
|
|
|
|
|
Refer to the explanation of adjustments on the next page.
35
EFFECTS OF THE RESTATEMENT
The adjustments relate to the following:
|
|
|
(a) |
|
To reflect the change in the revenue recognition method from the sell-in method to the
sell-through method. |
|
(b) |
|
To reflect other adjustments and reclassifications. |
|
(c) |
|
To reflect the effect of the sell-through revenue recognition method on cost of
products sold and royalties. |
|
(d) |
|
To reclassify expenses incurred for the technology transfer and validation effort
related to the second source of supply for AVINZA from research and development expense to
selling, general and administrative expense. |
|
(e) |
|
To expense the payment to The Salk Institute to buy-out the Companys royalty
obligation on lasofoxifene in March 2004. |
|
(f) |
|
To correct patent expense. |
|
(g) |
|
To correct legal expense. |
|
(h) |
|
To reclassify income taxes related to international operations. |
36
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 (or 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 Panretin 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 (or 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 2006 or early 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 hospitals beginning in March 2003. Organons compensation is structured
as a percentage of net sales, based on our standard accounting principles and generally accepted
accounting principles (GAAP), which pays Organon for their efforts and also provides Organon an
economic incentive for performance and results. In exchange, we pay 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 |
% |
$150-300 million |
|
|
40 |
% |
$300-425 million |
|
|
50 |
% |
> $425 million |
|
|
45 |
% |
Through the announcement of the restatement, we calculated and paid Organons compensation
according to our prior application of GAAP and our prior standard accounting principles. The
restatement corrects the recognition of revenue for transactions involving AVINZA that did not
satisfy all of the conditions for revenue recognition contained in SFAS 48 and SAB 104. Shipments
made to wholesalers for AVINZA did not meet the revenue recognition criteria under GAAP and such
transactions were restated using the sell-through method as opposed to the sell-in method
previously used.
Because this sell-in revenue was not in accordance with GAAP, we believe that we have overpaid
Organon under the terms of the agreement by approximately $11.5 million for sales through June 30,
2005. We have notified Organon regarding the overpayment and our intention to apply such
overpayment to amounts due under the co-promotion agreement calculated under GAAP and our standard
accounting principles. Organon has expressed its disagreement with this position and we are
currently in discussions with Organon. While the discussions continue, the payments made and under
discussion are reflected in the Companys consolidated financial statements as co-promotion
expense. Therefore, the consolidated financial statements included herein
do not recognize the overpayment pending resolution of the matter. Until this matter is
resolved, we will continue to account for co-promotion expense based on net sales determined using
the sell-in method.
37
Additionally, both companies agreed to share equally all costs for AVINZA advertising and
promotion, medical affairs and clinical trials. Each company is responsible for its own sales
force costs and other expenses. The initial term of the co-promotion agreement is 10 years.
Organon has the option any time prior to January 1, 2008 to extend the agreement to 2017 by making
a $75.0 million payment to us. Either party may terminate the agreement in the event that net
sales of AVINZA during 2007 are less than a specified level. Further, either party may terminate
the agreement upon material breach of the other party, including a failure of the other party to
meet at least 95% of its minimum sales calls obligations, or to use its commercially reasonable
efforts to market and promote AVINZA in accordance with the mutually agreed marketing plan, which
includes the number, targeting and frequency of sales calls.
We are currently involved in the research and development phase of a collaboration with TAP
Pharmaceutical Products Inc. (TAP). Collaborations in the development phase are being pursued by
Eli Lilly and Company, GlaxoSmithKline, Organon, Pfizer, TAP and Wyeth. We receive funding during
the research phase of the arrangements and milestone and royalty payments as products are developed
and marketed by our corporate partners. In addition, in connection with some of these
collaborations, we received non-refundable up-front payments.
We have been unprofitable since our inception on an annual basis. We achieved quarterly net
income of $17.3 million during the fourth quarter of fiscal 2004, which was primarily the result of
recognizing approximately $31.3 million from the sale of royalty rights to Royalty Pharma.
However, for the three and six months ended June 30, 2005, we incurred a net loss of $8.9 million
and $27.4 million, respectively, and expect to incur net losses in the future. 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 the timing of revenues earned from product
sales, expenses incurred, collaborative arrangements and other sources. Some of these fluctuations
may be significant.
Recent Developments
Acceleration of Stock Options
The Company accounts for stock-based compensation in accordance with Accounting Principles
Board Opinion (APB) No. 25, Accounting for Stock Issued to Employees, and FASB Interpretation No.
44, Accounting for Certain Transactions Involving Stock Compensation.
On January 31, 2005, we 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 our stock on that date. 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. Since the stock options
were out-of-the-money, no compensation expense was recognized for the six months ended June 30,
2005.
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 the Financial Accounting Standard Board statement Share-Based Payment
(SFAS 123R).
38
Sales Force activity/realignment
In March 2004, Ligand and Organon announced plans to increase sales calls in 2004 to primary
care physicians through increased call activity by Organons primary care sales force and by Ligand
hiring an additional 36 representatives calling on top decile primary care physicians in a mirrored
activity to Organons. The companies also announced plans for 2004 for increased calls to
long-term care and hospice market segments through the Organon sales and LTC/hospice
infrastructure. Although these initiatives were in place during the second, third and fourth
quarters of 2004, the sales call expansion and prescription increases anticipated were slower than
expected.
As part of an overall larger sales force realignment in Organon, a comprehensive territory
rebalancing and AVINZA sales force restructuring was implemented in November 2004. This
restructuring created approximately 370 AVINZA primary care territories with an
estimated 60 AVINZA primary care physicians in each, eliminated the specialty sales force and
placed specialty physicians into the hospital sales force call universe, and solidified a hospital
sales force of 110 representatives. The primary care sales force was essentially focused on AVINZA
and the hospital sales force called on specialists with AVINZA in position one.
While the increased focus of the primary care representatives and the territory rebalancing of
physicians was intended to be positive and increase sales call productivity over time, the
immediate and near term effects including sales force turnover appear to have impacted the quantity
and quality of expected sales calls in 2004 and continuing into 2005. In addition, the Organon
reorganization impacted the infrastructure and personnel available to execute the long-term care
and hospice initiatives. The Organon reorganization and rebalancing, and the Ligand primary care
sales force expansion are expected to improve sales call productivity in primary care over time,
however, reacceleration of prescription demand and market share gains have not yet responded in the
expected timeframes or in the expected quantities. This remains one of the key challenges of the
co-promotion partners going forward.
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 our royalty obligations on net
sales of ONTAK. Under the revised agreement, we and Lilly each obtained two options.
Our options, exercisable in January 2005 and April 2005, provided for the buy down of a portion of
our 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 we have
exercised one or both of our options.
Our first option, providing for a one-time payment of $20.0 million to Lilly in exchange for
the elimination of our ONTAK royalty obligations in 2005 and a reduced reverse-tiered royalty scale
on ONTAK sales in the U.S. thereafter, was exercised and paid in January 2005. The second option,
exercised and paid in April 2005, 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. Beginning in 2007 and throughout the remaining ONTAK patent
life (2014), we will pay no royalties to Lilly on U.S. sales up to $38.0 million. Thereafter,
Ligand would 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.
Targretin Capsules Development Programs
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. We are continuing to analyze the data and apply it to the continued development of
Targretin capsules in NSCLC. Failure to demonstrate the products safety and effectiveness in
NSCLC would delay or prevent regulatory approval of the product and could adversely affect our
business as well as our stock price. See Risk Factors Our products face significant regulatory
hurdles prior to marketing which could delay or prevent sales.
39
Additional Manufacturing Sources
In 2004, we entered into contracts with Cardinal Health to provide a second manufacturing
source for AVINZA, and with Hollister-Stier to fill and finish ONTAK. In July 2005, we announced
that the FDA approved the Hollister-Stier facility for fill/finish of ONTAK. In August 2005, the
FDA approved the production of AVINZA at the Cardinal Health facility, which provides a second
source of supply, thus diversifying the AVINZA supply chain and increasing production capacity.
Pfizer Collaboration Lasofoxifene
In August 2004, Pfizer submitted an NDA to the FDA for lasofoxifene for the prevention of
osteoporosis in postmenopausal women. In September 2005, Pfizer announced the receipt of a
non-approvable letter from the FDA for the prevention of osteoporosis. In December 2004, Pfizer
filed a supplemental NDA for the use of lasofoxifene for the treatment of vaginal atrophy which
remains pending at the FDA. Lasofoxifene is also being developed by Pfizer for the treatment of
osteoporosis. Lasofoxifene is a product that resulted from our collaboration with Pfizer and upon
which we will receive royalties if the product is approved by the FDA and subsequently marketed by
Pfizer.
Results of Operations
Total revenues for the three months ended June 30, 2005 were $45.8 million compared to $32.3
million for the same 2004 period. Loss from operations was $6.5 million for the three months ended
June 30, 2005 compared to $19.1 million for the same 2004 period. Net loss for the three months
ended June 30, 2005 was $8.9 million ($0.12 per share) compared to $22.1 million ($0.30 per share)
for the same 2004 period.
Total revenues for the six months ended June 30, 2005 were $82.8 million compared to $59.7
million for the same 2004 period. Loss from operations was $22.3 million for the six months ended
June 30, 2005 compared to $38.2 million for the same 2004 period. Net loss for the six months
ended June 30, 2005 was $27.4 million ($0.37 per share) compared to $44.0 million ($0.60 per share)
for the same 2004 period.
Effects of the Sell-Through Method on Consolidated Financial Statements
As described in the 2004 Form 10-K, the Company adopted the sell-through revenue recognition
method as its new revenue recognition policy for the Companys domestic products shipments of
AVINZA, ONTAK, Targretin capsules, and Targretin gel. Under the sell-through method, the Company
does not recognize revenue upon shipment of product to the wholesaler. The Company recognizes
revenue when such inventory is sold through on a first-in-first-out (FIFO) basis.
Sell-through for AVINZA is considered to be at the prescription level or at time of end user
consumption for non-retail prescriptions. Thus, changes in wholesaler or retail pharmacy
inventories of AVINZA do not affect the Companys product revenues, but will be reflected on the
balance sheet under deferred revenue, net. Sell-through for ONTAK, Targretin capsules and
Targretin gel is considered to be at the time the product moves from the wholesaler to the
wholesalers customer. Likewise, changes in wholesaler inventories of these products do not affect
the Companys product revenue, but will be reflected on the balance sheet under deferred revenue,
net. As such, changes in wholesaler inventories for all the Companys products, including product
that the wholesaler returns to the Company for credit, do not affect product revenues but will be reflected as a
change in deferred product revenue.
Under the sell-through revenue recognition method, product sales and gross margins are
affected by the timing of gross to net sales adjustments including wholesaler promotional
discounts, 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 the Companys products are further
impacted by the changes in the timing of revenue recognition and certain related changes in
accounting as a result of the change to the sell-through revenue recognition method. The more
significant impacts are summarized below:
40
|
|
|
Impact of changed sales volumes a significant amount of cost of products sold is
comprised of fixed costs including amortization of acquired technology and product rights
that result in lower margins at lower sales levels. |
|
|
|
|
Returns when product is shipped into the wholesale channel, inventory held by the
wholesaler (and subsequently held by retail pharmacies in the case of AVINZA) is classified
as deferred cost of product sold which is included in Other current assets. At the
time of shipment, the Company makes an estimate of units that may be returned and records a
reserve for those units against the deferred cost of goods sold account. Upon an
announced price increase, the Company revalues its estimate of deferred product revenue to
be returned to recognize the potential higher credit a wholesaler may take upon product
return determined as the difference between the new and the initial wholesaler acquisition
cost. The impact of this reserve revaluation is likewise reflected as a charge to the
Companys statement of operations in the period the Company announces such price increase. |
|
|
|
|
Royalties under the sell-through method, royalties paid based on unit shipments to
wholesalers are deferred and recognized as royalty expense as those units are sold-through
and recognized as revenue. |
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, 2005 was
4.5% compared to 3.8% for the same 2004 period. We expect that AVINZA prescription market share
will continue to increase as a result of a more balanced and focused sales and marketing activity
compared to 2004. We also continue to 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 but negatively impacted by continuing reimbursement trends resulting
from changes to the Centers for Medicare and Medicaid Services reimbursement rates. The level and
timing of any increases resulting from expanded-use clinical trials, 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.
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 150 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, 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 fee-for-service agreements discussed
below), our shipments and cash flow for that period could be substantially lower than historical
levels.
In the third and fourth quarters of 2004, we entered into fee-for-service agreements (or
distribution service agreements) for each of our products with the majority of our
wholesaler customers. The principal fee-for-service agreements were subsequently renewed during
the third quarter of 2005. In exchange for a set fee, the wholesalers have agreed to provide us
with certain information regarding product stocking and out-movement; agreed to maintain inventory
quantities within specified minimum and maximum levels; inventory handling, stocking and management
services; and certain other services surrounding the administration of returns and chargebacks. In
connection with implementation of the fee-for-service agreements, we no longer offer these
wholesalers promotional discounts or incentives and as a result, we expect a net improvement in
product gross margins as volumes grow. Additionally, we believe these arrangements will provide
lower variability in wholesaler inventory levels and improved management of inventories within and
between individual wholesaler distribution centers that we believe will result in a lower level of
product returns compared to prior periods.
41
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 the 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
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. 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, 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 our products and the expiration
of the underlying patents for each product is as follows:
|
|
|
|
|
|
|
|
|
|
|
Revenue Recognition |
|
Patent |
|
|
Method |
|
Event |
|
Expiration |
AVINZA
|
|
Sell-through
|
|
Prescriptions
|
|
November 2017 |
ONTAK
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
December 2014 |
Targretin capsules
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Targretin gel
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Panretin
|
|
Sell-in
|
|
Shipment to wholesaler
|
|
August 2016 |
International
|
|
Sell-in
|
|
Shipment to international distributor
|
|
February 2011 through April 2013 |
For the three months ended June 30, 2005 and 2004, net product sales recognized under the
sell-through method represented 96% and 97% of total net product sales and net product sales
recognized under the sell-in method represented 4% and 3%, respectively. For the six months ended
June 30, 2005 and 2004, net product sales recognized under the sell-through method represented 96%
of total net product sales and net product sales recognized under the sell-in method represented 4%
of total net product sales in 2005 and 2004.
42
Our total net product sales for the three months ended June 30, 2005 were $41.7 million
compared to $29.3 million for the same 2004 period. Total net product sales for the six months
ended June 30, 2005 were $76.8 million compared to $54.2 million for the same 2004 period. A
comparison of sales by product is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
2004 |
|
|
|
2005 |
|
|
(Restated) |
|
|
2005 |
|
|
(Restated) |
|
AVINZA |
|
$ |
27,461 |
|
|
$ |
14,177 |
|
|
$ |
49,458 |
|
|
$ |
27,454 |
|
ONTAK |
|
|
8,779 |
|
|
|
9,966 |
|
|
|
16,803 |
|
|
|
17,277 |
|
Targretin capsules |
|
|
4,671 |
|
|
|
4,136 |
|
|
|
8,686 |
|
|
|
7,553 |
|
Targretin gel and Panretin gel |
|
|
824 |
|
|
|
1,020 |
|
|
|
1,833 |
|
|
|
1,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
41,735 |
|
|
$ |
29,299 |
|
|
$ |
76,780 |
|
|
$ |
54,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVINZA
Sales of AVINZA were $27.5 million for the three months ended June 30, 2005 compared to $14.2
million for the same 2004 period. For the six months ended June 30, 2005, sales of AVINZA were
$49.5 million compared to $27.5 million for the same 2004 period. The increase in net product
sales for the three and six months ended June 30, 2005 is due to higher prescriptions as a result
of the increased level of marketing and sales activity under our co-promotion agreement with
Organon, and the products success in achieving state Medicaid and commercial formulary status.
Formulary access removes obstacles to physicians prescribing the product and facilitates patient
access to the product through lower co-pays. According to IMS data, quarterly prescription
market-share for AVINZA for the three months ended June 30, 2005 was 4.5% compared to 3.8% for the
same 2004 period. Since the start of co-promotion activities, AVINZA had been promoted by more
than 700 sales representatives compared to approximately 50 representatives in 2003 prior to
co-promotion. As a result of a recent sales force restructuring and rebalancing of the Organon
AVINZA sales territories, as further discussed above under Recent Developments, and the expansion
of Ligands sales force, four separate sales forces totaling approximately 600 representatives are
anticipated to be deployed throughout 2005 to provide more than 800,000 focused sales calls per
year to the primary care, specialist, and long-term care and hospice markets.
For the three and six months ended June 30, 2005 compared to the same 2004 period, AVINZA
sales were negatively impacted by a higher level of rebates under certain managed care contracts
with pharmacy benefit managers (PBMs), group purchasing organizations (GPOs) and health maintenance
organizations (HMOs).
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
determined as the difference between the new price and the previous price used to value the
allowance. AVINZA sales for the six months ended June 30, 2005 reflect an approximate $3.5 million
reduction in sales, recorded for the three months ended March 31, 2005, for losses expected to be
incurred on product returns resulting from an AVINZA price increase which became effective April 1,
2005. This compares to a $2.6 million loss on product returns recorded for the three months ended
June 30, 2004 for an AVINZA price increase which became effective July 1, 2004. Lastly, product
sales for the three and six months ended June 30, 2005 are net of fees paid to our wholesaler
customers under the fee for service agreements entered into during the third and fourth quarters of
2004.
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, 2005 could result in adjustments to our Medicaid
and managed care contract rebate accruals and net product sales of approximately $1.1 million and
$0.4 million, respectively.
ONTAK
Sales of ONTAK were $8.8 million for the three months ended June 30, 2005 compared to $10.0
million for the same 2004 period. For the six months ended June 30, 2005, sales of ONTAK were
$16.8 million compared to $17.3 million for the same 2004 period. The decrease in net product
sales for the three and six months ended June 30, 2005 compared to the same periods in 2004
reflects a 12% and 4% decrease in wholesaler out-movement, respectively, due primarily to a decline
in the office segment of the market which has been impacted by reimbursement rates. Increases in
the hospital segment have not been sufficient to offset the office segment trend.
43
ONTAK sales for the three and six month period were also negatively impacted by a continued increase in chargebacks
and rebates due to changes in patient mix and evolving reimbursement rates. These decreases were
partially offset by a 9% price increase effective January 1, 2004, which under the sell-through
revenue recognition method does not impact net product sales until the product sells through the
distribution channel and therefore only had a limited impact on net sales for the same 2004
periods. Net product sales for the 2004 periods are also net of promotional discounts and amounts
paid to wholesalers for marketing support. In connection with the implementation of fee for
service agreements in the third quarter of 2004, the Company no longer provides to wholesalers
promotional discounts or marketing support payments. The impact of lower discounts and marketing
support payments in the 2005 periods on net product sales is partially offset by fees paid to
wholesalers under the fee for service agreements.
We continue to study changes to the Centers for Medicare and Medicaid Services reimbursement
rates. This review continues to indicate increased challenges for a sub-segment of our ONTAK
Medicare patients in 2005. We expect that sales of ONTAK will continue to be negatively impacted
by changes to the Centers for Medicare and Medicaid Services reimbursement rates in 2005 but expect
improved reimbursement rates moving into 2006.
Targretin capsules
Sales of Targretin capsules were $4.7 million for the three months ended June 30, 2005
compared to $4.1 million for the same 2004 period. For the six months ended June 30, 2005, sales
of Targretin capsules were $8.7 million compared to $7.6 million for the same 2004 period. This
increase reflects a 7% price increase effective January 1, 2004 which under the sell-through
revenue recognition method does not impact net product sales until the product sells-through the
distribution channel and therefore had only a limited impact on net sales for the same 2004 period.
As reported by IMS Health, demand for Targretin capsules, as measured by product outmovement,
increased by approximately 4% and 2% for the three and six months ended June 30, 2005,
respectively, compared to the same 2004 periods. Lastly, Targretin capsules product sales are net
of fees paid to our wholesaler customers under the fee for service agreements entered into during
the third and fourth quarters of 2004.
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 CTCL. As a result, we
continue to expect improved patient access for Targretin in 2005.
Collaborative Research and Development and Other Revenues
Collaborative research and development and other revenues for the three months ended June 30,
2005 were $4.1 million compared to $3.0 million for the same 2004 period. For the six months ended
June 30, 2005, collaborative research and development and other revenues were $6.0 million compared
to $5.5 million for the same 2004 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 SAB 104. Revenue
from distribution agreements includes recognition of up-front fees collected upon contract signing
and deferred over the life of the distribution arrangement and milestones achieved under such
agreements.
A comparison of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Collaborative research and development |
|
$ |
862 |
|
|
$ |
2,147 |
|
|
$ |
1,724 |
|
|
$ |
4,319 |
|
Development milestones and other |
|
|
3,202 |
|
|
|
828 |
|
|
|
4,280 |
|
|
|
1,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,064 |
|
|
$ |
2,975 |
|
|
$ |
6,004 |
|
|
$ |
5,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative research and development. The decrease in ongoing research activities
reimbursement revenue for the three and six months ended June 30, 2005 compared to the same 2004
period is due to the termination in November 2004 of our research arrangement with Lilly.
44
Development milestones and other. Development milestone revenue for the three months ended
June 30, 2005 reflects $2.0 million earned from GlaxoSmithKline and $1.1 million earned from TAP.
For the six months ended June 30, 2005, development milestone revenue also includes an additional
$1.0 million earned from GlaxoSmithKline.
Gross Margin
Gross
margin on product sales was 74.4% for the three months ended June 30, 2005 compared to
66.8% for the same 2004 period. For the six months ended June 30, 2005, gross margin on product
sales was 71.7% compared to 68.2% for the same 2004 period.
The increase in the margin for the three and six months ended June 30, 2005 compared to the
same 2004 period is primarily due to the increase in sales of AVINZA. AVINZA represented 65.8% and
64.4% of net product sales for the three and six months ended 2005 compared to 48.4% and 50.6% for the same 2004
periods, respectively. 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 capitalized license and
royalty rights, $114.4 million, is being amortized to cost of product sold on a straight-line basis
over 15 years. The total amount of ONTAK acquired technology, $45.3 million, is also amortized to
cost of product sold on a straight-line basis over 15 years. ONTAK margins were also positively
impacted during the three and six months ended June 30, 2005 by lower royalties as a result of the
partial impact of the restructuring of the Companys royalty obligation to Lilly as further
discussed under Recent Development Restructuring of ONTAK Royalty. This restructuring resulted
in no royalty liability owed to Lilly for the three and six months ended June 30, 2005. This
impact was partially offset by amortization of the $33.0 million paid to Lilly as of June 30, 2005
to restructure the ONTAK royalty and the recognition of deferred royalty expense previously paid to
Lilly which under the sell-through revenue recognition method is recognized as the related product
sales are recognized. The amount paid to restructure the ONTAK royalty 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 under Restructuring of ONTAK
Royalty above.. 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, 2005, acquired technology and products rights,
net totaled $153.8 million.
Gross margins for the three and six months ended June 30, 2005 were also favorably impacted by
price increases on ONTAK, Targretin capsules and Targretin gel which became effective January 1,
2004 and for AVINZA which became effective July 1, 2004. 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 significant effect on the margins for the three and six months ended June 30, 2004.
Gross margin for the three and six months ended June 30, 2005 compared to the same 2004 period
was negatively impacted, however, by a higher proportionate level of AVINZA rebates and
ONTAK chargebacks and rebates and the costs associated with our wholesaler distribution service
agreements as further discussed under Product Sales. Additionally, gross margin for the six
months ended June 30, 2005 compared to the same 2004 period was negatively impacted by a $0.5
million write-off of ONTAK finished goods inventory in the quarter ended March 31, 2005, due to the
Companys updated assessment in December 2005 of the timing of certain clinical trials.
Overall, given the fixed level of amortization of the capitalized AVINZA license and royalty
rights, we expect the AVINZA gross margin percentage to continue to increase as sales of AVINZA
increase. Additionally, we expect the gross margin on ONTAK to further improve in 2005 due to the
lowering of the royalty obligation to Lilly in connection with the restructuring of the ONTAK
royalty agreement as further discussed under Recent Developments.
45
Research and Development Expenses
Research and development expenses were $14.5 million for the three months ended June 30, 2005
compared to $16.6 million for the same 2004 period. For the six months ended June 30, 2005,
research and development expenses were $29.3 million compared to $34.1 million for the same 2004
period. The major components of research and development expenses are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
2004 |
|
|
|
2005 |
|
|
(Restated) |
|
|
2005 |
|
|
(Restated) |
|
Research |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research performed under collaboration agreements |
|
$ |
1,013 |
|
|
$ |
1,887 |
|
|
$ |
1,995 |
|
|
$ |
3,972 |
|
Internal research programs |
|
|
5,354 |
|
|
|
3,781 |
|
|
|
10,331 |
|
|
|
7,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research |
|
$ |
6,367 |
|
|
$ |
5,668 |
|
|
$ |
12,326 |
|
|
$ |
11,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
New product development |
|
$ |
5,227 |
|
|
$ |
7,520 |
|
|
$ |
11,323 |
|
|
$ |
15,455 |
|
Existing product support (1) |
|
|
2,930 |
|
|
|
3,378 |
|
|
|
5,610 |
|
|
|
6,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total development |
|
$ |
8,157 |
|
|
$ |
10,898 |
|
|
$ |
16,933 |
|
|
$ |
22,410 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
14,524 |
|
|
$ |
16,566 |
|
|
$ |
29,259 |
|
|
$ |
34,083 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes costs incurred to comply with post-marketing regulatory commitments. |
Spending for research expenses increased to $6.4 million for the three months ended June 30,
2005 compared to $5.7 million for the same 2004 period. For the six months ended June 30, 2005,
research expenses amounted to $12.3 million compared to $11.7 million for the same 2004 period.
The overall increase for the three and six months ended June 30, 2005 is due to an increased level
of internal program research in the area of thrombopoietin (TPO) agonists. This increase is
partially offset by a decrease in research performed under collaboration agreements due primarily
to a lower contractual level of research funding under our agreement with TAP and lower research
funding under the Lilly collaboration which concluded in November 2004.
Spending for development expenses decreased to $8.2 million for the three months ended June
30, 2005 compared to $10.9 million for the same 2004 period and to $16.9 million for the six months
ended June 30, 2005 compared to $22.4 million for the same 2004 period. These decreases reflect a
lower level of expense for both new product development and existing product support. The decrease
in expenses for new product development is due primarily to a reduced level of spending on Phase
III clinical trials for Targretin capsules in NSCLC. In March 2005, we announced that the final
data analysis for Targretin capsules in NSCLC showed that the trials did not meet their endpoints
of improved overall survival and projected two-year survival. We are continuing to analyze the
data and apply it to the continued development of Targretin in NSCLC. The decrease in existing
product support in 2005 as compared to 2004 is primarily due to lower expenses for Targretin
capsules and ONTAK post-marketing regulatory studies.
As a result of the findings for Targretin capsules in NSCLC, we expect overall development
expenses to further decrease in 2005 compared to 2004.
46
A summary of our significant internal research and development programs is as follows:
|
|
|
|
|
Program |
|
Disease/Indication |
|
Development Phase |
AVINZA
|
|
Chronic, moderate-to-severe pain
|
|
Marketed in U.S. |
|
|
|
|
Phase IV |
|
|
|
|
|
ONTAK
|
|
CTCL
|
|
Marketed in U.S., Phase IV |
|
|
Chronic lymphocytic leukemia
|
|
Phase II |
|
|
Peripheral T-cell lymphoma
|
|
Phase II |
|
|
B-cell Non-Hodgkins lymphoma
|
|
Phase II |
|
|
NSCLC third line
|
|
Phase II |
|
|
|
|
|
Targretin capsules
|
|
CTCL
|
|
Marketed in U.S. and Europe |
|
|
NSCLC first-line
|
|
Phase III |
|
|
NSCLC monotherapy
|
|
Planned Phase II/III |
|
|
NSCLC second/third line
|
|
Planned Phase II/III |
|
|
Advanced breast cancer
|
|
Phase II |
|
|
Renal cell cancer
|
|
Phase II |
|
|
|
|
|
Targretin gel
|
|
CTCL
|
|
Marketed in U.S. |
|
|
Hand dermatitis (eczema)
|
|
Planned Phase II/III |
|
|
Psoriasis
|
|
Phase II |
|
|
|
|
|
LGD4665 (Thrombopoietin oral mimic)
|
|
Chemotherapy-induced thrombocytopenia
(TCP), other TCPs
|
|
IND Track |
|
|
|
|
|
LGD5552 (Glucocorticoid agonists)
|
|
Inflammation, cancer
|
|
IND Track |
|
|
|
|
|
Selective androgen receptor modulators, e.g.,
LGD3303 (agonist/antagonist)
|
|
Male hypogonadism, female & male
osteoporosis, male & female sexual
dysfunction, frailty. Prostate cancer,
hirsutism, acne, androgenetic alopecia.
|
|
Pre-clinical |
We do not provide forward-looking estimates of costs and time to complete our ongoing research
and development projects, as such estimates would involve a high degree of uncertainty.
Uncertainties include our ability to predict the outcome of complex research, our ability to
predict the results of clinical studies, regulatory requirements placed upon us by regulatory
authorities such as the FDA and EMEA, our ability to predict the decisions of our collaborative
partners, our ability to fund research and development programs, competition from other entities of
which we may become aware in future periods, predictions of market potential from products that may
be derived from our research and development efforts, and our ability to recruit and retain
personnel or third-party research organizations with the necessary knowledge and skills to perform
certain research. Refer to Risk Factors below for additional discussion of the uncertainties
surrounding our research and development initiatives.
Selling, General and Administrative Expense
Selling, general and administrative expense was $20.1 million for the three months ended June
30, 2005 compared to $18.1 million for the same 2004 period. For the six months ended June 30,
2005, selling, general and administrative expense was $39.4 million compared to $32.8 million for
the same 2004 period. The increase for the three and six months ended June 30, 2005 is primarily
due to costs associated with additional Ligand sales representatives hired to promote AVINZA and
higher advertising and promotion expenses for AVINZA, ONTAK and Targretin capsules. The 2005
periods also reflect higher accounting and legal expenses incurred in connection with the Audit
Committees review of the Companys consolidated financial statements, the restatement, and ongoing
shareholder litigation. Selling, general and administrative expense is expected to further
increase in 2005 due to the full year impact of hiring of an additional 36 pain specialist sales
representatives as discussed above and due to
47
significantly higher accounting and legal expenses incurred in connection with the restatement
of our consolidated financial statements, SEC investigation and shareholder litigation.
Co-promotion Expense
Co-promotion expense under our co-promotion arrangement with Organon amounted to $7.0 million
for the three months ended June 30, 2005 compared to $7.0 million for the same 2004 period. For
the six months ended June 30, 2005, co-promotion expense was $14.7 million compared to $13.7
million for the same 2004 period. As discussed under Overview, we pay Organon, under the terms
of our co-promotion agreement, 30% of net AVINZA sales, determined in accordance with GAAP and our
standard accounting principles up to $150.0 million and higher percentage payments for net sales in
excess of $150.0 million. Co-promotion expense recognized for the 2005 and 2004 quarterly periods
was determined based upon the Companys shipments of AVINZA to wholesalers under the sell-in
revenue recognition method. As further discussed under Overview, however, AVINZA shipments made
to wholesalers did not meet the revenue recognition criteria under GAAP and such transactions were
restated using the sell-through method. For the three and six months ended June 30, 2004, net
AVINZA product sales under the sell-in method were higher than net product sales under the
sell-through method. Accordingly, co-promotion expense for these periods is higher than 30% of the
reported net AVINZA product sales under the sell-through method.
Because this sell-in revenue was not in accordance with GAAP, we believe that we have overpaid
Organon under the terms of the agreement by approximately $11.5 million for sales through June 30,
2005. We have notified Organon regarding the overpayment and our intention to apply such
overpayment to amounts due under the co-promotion agreement calculated under GAAP and our standard
accounting principles. Organon has expressed its disagreement with this position and we are
currently in discussions with Organon. While the discussions continue, the payments made and under
discussion are reflected in the Companys consolidated financial statements as co-promotion
expense. Therefore, the consolidated financial statements included herein do not recognize the
overpayment pending resolution of the matter. Until this matter is resolved, we will continue to
account for co-promotion expense based on net sales determined using the sell-in method.
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 $104.9 million at June 30, 2005 compared to a deficit of
$48.5 million at December 31, 2004. Cash, cash equivalents, short-term investments, and restricted
investments totaled $70.1 million at June 30, 2005 compared to $114.9 million at December 31, 2004.
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 $10.5 million for the six months ended June 30, 2005
compared to $16.4 million for the same 2004 period. The lower use of cash for the 2005 period
reflects the changes in operating assets and liabilities primarily due to the decrease in accounts
receivable, 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 the decrease in accounts payable and
accrued liabilities of $4.1 million. For the same 2004 period, use of operating cash was impacted
by the changes in operating assets and liabilities primarily due to the increase in deferred
revenue, net of $18.0 million, the increase in accounts payable and accrued liabilities of $4.5
million, and a decrease in accounts receivable, net of $1.1 million, partially offset by an
increase in inventories, net of $3.5 million.
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We expect operating cash flows to continue to benefit in 2005 from increased product demand
due primarily to growth in AVINZA. Operating cash is expected to be negatively impacted, however,
by lower product shipments to wholesalers in accordance with reduced wholesaler inventory levels we
negotiated with our major wholesaler customers under our distribution service agreements. The cash
impact of the lower shipments is expected to be partially offset by lower fees paid under the
distribution service agreements. Operating cash flows are expected to be further negatively
impacted by higher selling and marketing expenses on AVINZA and increased accounting
and legal expenses incurred in connection with the restatement of our consolidated financial
statements.
Investing Activities
Investing activities used cash of $49.9 million for the six months ended June 30, 2005
compared to $6.3 million for the same 2004 period. The use of cash for the six months ended June
30, 2005 reflects $33.0 of payments 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.
Cash used for the six months ended June 30, 2004 primarily reflects $8.5 million of net purchases
of short-term investments, a decrease in restricted investments of $4.6 million and $2.0 million of
purchases of property and equipment.
Financing Activities
Financing activities provided cash of $0.7 million for the six months ended June 30, 2005
compared to $5.6 million for the same 2004 period. 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. Cash provided by
financing activities for the six months ended June 30, 2004 includes proceeds from the exercise of
employee stock options and purchases under the Companys employee stock purchase plan and net
proceeds from equipment financing arrangements of $4.6 million and $1.2 million, respectively.
Certain of our property and equipment is pledged as collateral under various equipment
financing arrangements. As of June 30, 2005, $6.5 million was outstanding under such arrangements
with $2.6 million classified as current. Our equipment financing arrangements have terms of three
to five years with interest ranging from 4.73% to 10.66%.
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; 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 ability to establish additional
collaborations or changes in existing collaborations; the efforts of our collaborators; and the
cost of production. We will also consider additional equipment financing arrangements similar to
arrangements currently in place.
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, 2005, we are not involved in any off-balance sheet arrangements.
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Contractual Obligations
In November 2002, Ligand and Elan agreed to amend the terms of the AVINZA license and supply
agreement. Under the terms of the amendment, we paid Elan $100.0 million in return for a reduction
in Elans product supply price on sales of AVINZA by Ligand, rights to sublicense and obtain a
co-promotion partner in its territories, and rights to qualify, and purchase AVINZA from a second
manufacturing source. Elans adjusted royalty and supply price of AVINZA is approximately 10% of
the products net sales. We also committed to purchase an annual minimum number of batches of
AVINZA from Elan through 2005 estimated at approximately $9.2 million per year.
In March 2004, we entered into a five-year manufacturing and packaging agreement with Cardinal
Health PTS, LLC (Cardinal) under which Cardinal will manufacture AVINZA at its Winchester,
Kentucky facility. Under the terms of the agreement, we committed to certain minimum annual
purchases ranging from approximately $1.6 million to $2.3 million. In August 2005, the FDA
approved the production of AVINZA at the Cardinal facility.
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 there have been no material changes during the quarter ended June 30,
2005 to the critical accounting policies reported in the Managements Discussion and Analysis
section of our annual report on Form 10-K for the year ended December 31, 2004.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
At June 30, 2005, our investment portfolio included fixed-income securities of $33.6 million.
At June 30, 2005, we held no other market risk sensitive instruments. Our fixed-income securities
are subject to interest rate risk and will decline in value if interest rates increase. This risk
is mitigated, however, due to the relatively short effective maturities of the debt instruments in
our investment portfolio. Accordingly, 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 would, however, reduce our interest income.
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.
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, 2005,
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, 2005 due to the material
weaknesses described in the Companys management report on internal control over financial
reporting included in Item 9A to its 2004 Form 10-K and outlined below. As of June 30, 2005, the
material weaknesses identified in the 2004 Form 10-K have not been fully remediated. Additionally,
since the material weaknesses described below have not been fully remediated, the CEO and CFO
continue to conclude that the Companys disclosure controls and procedures are not effective as of
the filing date of this Form 10-Q.
As disclosed in the 2004 Form 10-K, management identified the following material weaknesses in
connection with its assessment of the effectiveness of the Companys internal control over
financial reporting as of December 31, 2004:
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The Company did not have effective controls and procedures to ensure that revenues,
including sales of its products and the practice it followed regarding the replacement
of expired products, were recognized in accordance with generally accepted accounting
principles. With respect to product sales, the Company did not have the ability to
make reasonable estimates of returns which preclude the Company from recognizing
revenue at the time of domestic product shipment of AVINZA, ONTAK, Targretin capsules,
and Targretin gel. As a result, shipments made to wholesalers for these products did
not meet the revenue recognition criteria of SFAS 48 Revenue Recognition When Right
of Return Exists and Staff Accounting Bulletin (SAB) No. 101 Revenue Recognition
as amended by SAB 104. |
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The Companys controls and procedures intended to prevent shipping of short-dated
products (i.e. products shipped within six months of expiration) to its wholesalers
were not operating effectively which resulted in the shipment of ONTAK during 2004 to
wholesalers within six months of product expiration. The shipment of short-dated
product subsequently resulted in significant product returns/replacements. |
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The Company did not have adequate records and documentation supporting the decisions
made and the accounting for past transactions. This material weakness resulted from
the fact that the Company did |
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not have sufficient controls surrounding the preparation and maintenance of adequate
contemporaneous records and documentation. |
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The Company did not have adequate manpower in its accounting and finance department
and has a lack of sufficient qualified accounting personnel to identify and resolve
complex accounting issues in accordance with generally accepted accounting principles.
This material weakness contributed to the following errors in accounting: (1) revenue
recognition, (2) revenues received under our agreement with Royalty Pharma, (3)
warrants issued in connection with the X-Ceptor transaction, (4) the classification of
the Elan shares in connection with the Companys purchase obligation relating to the
November 2002 restructuring of the AVINZA license agreement with Elan and the shares of
stock issued to Pfizer in connection with the Pfizer Settlement Agreement, (5) accrual
of interest in connection with the Seragen litigation, and (6) the calculation of
contractual annual rent increases. |
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The Company did not have sufficient controls over accrued liabilities estimations in
the proper accounting periods (i.e., accruals and cut-off). This material weakness
caused errors in accounting relating to (1) estimation of accruals for clinical trials,
bonuses to employees, and other miscellaneous accrued liabilities, and (2) royalty
payments made to technology partners. |
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The Company did not have adequate financial reporting and close procedures. This
material weakness resulted from the fact that the Company did not have sufficient
controls in place nor trained personnel to adequately prepare and review documentation
and schedules necessary to support its financial reporting and period-end close
procedures. |
b) Remediation Steps to Address Material Weakness.
As described below, during the quarter ended June 30, 2005, we have implemented, or plan to
implement, the following measures to remediate the material weaknesses described above and in our
2004 Form 10-K.
Revenue Recognition.
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During the second and third quarters of 2005, the
Companys finance and accounting department, with the
assistance of outside expert consultants, developed
accounting models to recognize sales of its 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 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,
required for sell-through revenue recognition. |
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The Companys commercial operations department is
additionally implementing a number of improvements that
will further enhance the controls surrounding the
recognition of product revenue. These include the
development of an information operations system that
will provide management with a greater amount of
reliable, timely data including product movement, demand
and inventory levels. The department is also adding
additional personnel to review, analyze and report this
information. |
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During the second and third quarters of 2005, the
accounting and finance department established 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. |
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The Company will hire an expert manager on revenue
recognition who will be responsible for managing all
aspects of the Companys revenue recognition accounting,
sell-through revenue recognition models and supporting
controls and procedures. The Company expects that this
position will be filled during the first quarter of
2006. However, until this position is filled, the
Company will continue to use outside expert consultants
to fulfill this function. |
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The Company is developing a training program for its
accounting and finance and commercial operations
personnel regarding the sell-through revenue recognition
method. The core training program is expected to be
implemented by the end of the fourth quarter of 2005.
Additional training will be provided on a regular and
periodic basis and updated as considered necessary. |
Shipments of Short-Dated Product.
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During the second quarter of 2005, the Companys
internal audit department conducted a detailed audit of
the controls, policies and procedures surrounding, and
the personnel responsible for, the shipment of the
Companys products. This internal audit resulted in
recommended remediation actions that were subsequently
implemented in the second and third quarters of 2005 by
the Companys technical and supply operations
department, including: |
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A review of all existing policies and procedures surrounding the shipment of
the Companys products. In connection with this review a number of enhancements were
made to the existing policies and procedures including daily review and reconciliation
of the Companys inventory report to the third party vendors inventory report for
verification of the distribution date and expiration date and daily review of third
party vendors sales report for verification that all products shipped had appropriate
dating. These review procedures are now performed by a senior-level staff person in
the Companys supply operations department. |
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Each of the Companys employees involved in the shipment of product received
training regarding the controls and procedures surrounding the shipment of product.
Additional training will be provided on a regular and periodic basis and updated as
considered necessary to reflect any changes in the Companys or its customers business
practices or activities. |
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Management also ensured that its third-party vendor responsible for product
inventories, shipping and logistics is aware and understands all applicable controls
and procedures surrounding product shipment and the requirement to prepare and maintain
appropriate documentation for all such product transactions. The third-party vendor
has instituted controls in its accounting system to prevent the shipment of product
that is not within the Companys shipping policies. |
Record Keeping and Documentation.
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The Company is in the process of implementing 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 and the development of additional
procedures for preparing and maintaining documentation is
expected to be completed in the fourth quarter of 2005. |
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The Companys accounting and finance and legal departments are
developing a formal policy regarding the preparation and
maintenance of contemporaneous documentation supporting
accounting transactions and contractual interpretations. The
formal policy, which will also provide for enhanced
communication between the Companys finance and legal
personnel, is expected to be completed during the fourth
quarter of 2005. |
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The Companys internal audit department will also routinely
audit the adequacy of the Companys internal record keeping
and documentation. |
Accounting Personnel.
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During the second quarter of 2005, the Company hired a second
internal auditor reporting to the Companys Director of
Internal Audit. The Companys Director of Internal Audit has
resigned effective as of December 2, 2005. The Company is in
the process of filling this position which is expected to be
filled in the first quarter of 2006. |
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During the second, third, and fourth quarters of 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 will hire additional senior accounting personnel
who are certified public accountants including a Director of
Accounting and, as discussed above, a Director of Internal
Audit and a Manager of Revenue Recognition. The Director of
Accounting, Director of Internal Audit, and the Manager of
Revenue Recognition positions are expected to be filled during
the first quarter of 2006. Until all such positions are
filled, the Company will continue to use outside expert
accounting consultants to fulfill such functions. |
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The Company continues to consider alternatives for
organizational or responsibility changes which it believes may
be necessary to attract additional senior accounting personnel
who are certified public accountants or have recent public
accounting firm experience. |
Accruals and Cut-off. During 2004 and continuing into 2005, the following controls and procedures
were implemented in the accounting and finance department.
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Developed monthly review procedures to review applicable
documentation for supporting period-end accruals. |
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Developed quarterly review procedures to review invoices to ensure
that such invoices were properly accounted for in the correct
period. |
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Completed training of accounting and finance personnel to explain
accrual methodologies and supporting documentation requirements.
Additional training will be provide on a regular basis and updated
as considered necessary to reflect changes in the Companys
accounting system. |
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The Companys internal audit department will perform periodic
reviews and audits of the Companys controls surrounding accruals
and cut-off. |
Financial Reporting and Close Procedures
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The Company intends to design and implement process improvements concerning the Companys
financial reporting and close procedures. In this regard, the Company will conduct training
sessions during the fourth quarter of 2005 or early 2006 and on a regular quarterly basis to
provide training to its finance and accounting personnel 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 procedures As discussed above, the
additional management personnel to be hired into the department will also help ensure that all
documentation necessary for the financial reporting and period end close procedures are
properly prepared and reviewed. |
c) Changes in internal control over financial reporting.
Except for changes in connection with the remediation subsequent to December 31, 2004 of the
material weaknesses described above, there was no change in the Companys internal control over
financial reporting that occurred during our second fiscal quarter ended June 30, 2005 that has
materially affected, or are reasonably likely to materially affect, its internal control over
financial reporting.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Seragen, Inc., our subsidiary, 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 our acquisition
subsidiary, Knight Acquisition Corporation, were dismissed from the action. Claims of breach of
fiduciary duty remain against the remaining defendants, including the former officers and directors
of Seragen. The hearing on the plaintiffs motion for class certification took place on February
26, 2001. 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. The Court denied plaintiffs motion for summary judgment in its entirety. Trial
was scheduled for February 7, 2005. 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. The timing of a decision by the Court and
the outcome are unknown. While Ligand and its subsidiary Seragen have been dismissed from the
action, such dismissal is subject to a possible subsequent appeal upon any judgment in the action
against the remaining parties, as well as possible indemnification obligations with respect to
certain defendants.
On December 11, 2001, a lawsuit was filed in the United States District Court for the District
of Massachusetts against Ligand by the Trustees of Boston University and other former stakeholders
of Seragen. The suit was subsequently transferred to federal district court in Delaware. The
complaint alleges breach of contract, breach of the implied covenants of good faith and fair
dealing and unfair and deceptive trade practices based on, among other things, allegations that
Ligand wrongfully withheld approximately $2.1 million in consideration due the plaintiffs under the
Seragen acquisition agreement. This amount had been previously accrued for in the Companys
consolidated financial statements in 1998. The complaint seeks payment of the withheld
consideration and treble damages. Ligand filed a motion to dismiss the unfair and deceptive trade
practices claim. The Court subsequently granted Ligands motion to dismiss the unfair and
deceptive trade practices claim (i.e. the treble damages claim), in April 2003. In November 2003,
the Court granted Boston Universitys motion for summary judgment, and entered judgment for Boston
University. In January 2004, the district court issued an amended judgment awarding interest of
approximately $0.7 million to the plaintiffs in addition to the approximately $2.1 million
withheld. In view of the judgment, the Company restated its consolidated financial statements to
record a charge of $0.7 million to Selling, general and administrative expense in the fourth
quarter of 2003. The appeal has been fully briefed and was argued in June 2005 and the parties are
awaiting the courts decision. The Company continues to believe that the plaintiffs claims are
without merit and has appealed the judgment in this case as well as the award of interest and the
calculation of damages. The likelihood of success on appeal is unknown.
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 on 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. No trial date has been set.
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Beginning on or about August 13, 2004, several derivative actions were filed on behalf of the
Company by individual stockholders in the Superior Court of California. The complaints name the
Companys directors and certain of its officers as defendants and name the Company as a nominal
defendant. The complaints are based on the same facts and circumstances as the purported class
actions discussed in the previous paragraph and generally allege breach of fiduciary duties, abuse
of control, waste and mismanagement, insider trading and unjust enrichment. These actions are in
discovery. The court has set a trial date of May 26, 2006.
In October 2005, a shareholder derivative action was filed on behalf of the Company in the
United States District Court for the Southern District of California. The complaint names the
Companys directors and certain of its officers as defendants and the Company as a nominal
defendant. The action was brought by an individual stockholder. The complaint generally alleges
that the defendants falsified Ligands publicly reported financial results throughout 2002 and 2003
and the first three quarters of 2004 by improperly recognizing revenue on product sales. The
complaint generally alleges breach of fiduciary duty by all defendants and requests disgorgement,
e.g., under Section 304 of the Sarbanes-Oxley Act of 2002. No trial date has been set.
The Company believes that all of the above actions are without merit and intends to vigorously
defend against each of such lawsuits. Due to the uncertainty of the ultimate outcome of these
matters, the impact on future financial results is not subject to reasonable estimates.
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 requested the
Court to set a time and place and record date for such annual meeting and establish the quorum for
such meeting as the shares present at the meeting, notwithstanding any relevant provisions of
Ligands certificate of incorporation or bylaws. 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. The record date for the meeting is December 15, 2005. On
December 2, 2005, Ligand and Third Point also entered into a stockholders agreement under which,
among other things, Ligand will 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, with some conditions. Third Point will not sell its Ligand shares,
solicit proxies or take certain other stockholder actions for a minimum of six months and as long
as its designees remain on the board.
In connection with the restatement, the SEC instituted a formal investigation concerning the
Companys 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.
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.
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, 2004. 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.
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Risks Related To Us and Our Business.
The restatement of our 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 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 Note 2 to the Consolidated Financial Statements in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2004 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 have 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 such costs as noted below. |
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We have been named in a number of lawsuits that began in August 2004 claiming to be
class actions and shareholder derivative actions. Additionally, in October 2005, we, our
directors, and certain of our officers were named in a shareholder derivative action which
was filed in the United States District Court for the Southern District of California. As
a result of our restatement the plaintiffs in these lawsuits may make additional claims,
expand existing claims and/or expand the time periods covered by the complaints. Other
plaintiffs may bring additional actions with other claims, based on the restatement. If
such events occur, we may incur additional substantial defense costs regardless of their
outcome. Likewise, such events might cause a diversion of our managements time and
attention. If we do not prevail in any such actions, we could be required to pay
substantial damages or settlement costs. |
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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. |
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The need to reconsider our accounting treatment and the restatement of our consolidated
financial statements caused us to be late in filing our required reports on Form 10-K for
December 31, 2004 and Forms 10-Q for the quarters ended March 31, 2005 and June 30, 2005,
respectively, which caused us to be delisted from NASDAQ National Market. See Our common
stock was delisted from the NASDAQ National Market which may reduce the price of our common
stock and the levels of liquidity available to our stockholders and cause confusion among
investors for additional discussion regarding the NASDAQ delisting. |
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The Company has entered into a long term factoring arrangement under which eligible
accounts receivable are sold without recourse to a finance company. The agreement requires
that the Companys consolidated financial statements be provided within 120 days after year
end. A waiver of the financial reporting covenant has been granted through December 31,
2005. Our inability to maintain the waivers of the financial reporting covenant could
impact our ability to continue factoring our receivables. Our inability to obtain adequate
working capital through the factoring arrangement could adversely affect our business and
our liquidity. |
57
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. In November 2005, we restated our consolidated financial
statements for the years ended 2002 and 2003, and the 2003 quarterly periods and first three
quarters of 2004. We also identified and reported a number of material weaknesses in our internal
control over financial reporting, as described in Item 9A of our Annual Report on Form 10-K for the
period ended December 31, 2004.
As a result of these material weaknesses, managements assessment concluded that the Companys
internal control over financial reporting is ineffective. Some of the identified material
weaknesses have not been fully addressed. It is also possible that additional material weaknesses
will be identified in the future. Until we remediate the remaining material weaknesses we have the
risk of another restatement.
The material weaknesses in our internal control over financial reporting related to the lack
of controls and procedures to ensure that revenues are recognized in accordance with generally
accepted accounting principles, the lack of controls and procedures to prevent shipping of
short-dated products, the lack of adequate manpower and insufficient qualified accounting personnel
to identify and resolve complex accounting issues, the lack of adequate record keeping and
documentation of past transactional accounting decisions, the lack of controls over accruals and
cut-offs, and the lack of controls surrounding financial reporting and close procedures.
Because we have concluded that our internal control over financial reporting is not effective
and our independent registered public accountants issued an adverse opinion on the effectiveness of
our internal controls, and to the extent we identify future weaknesses or deficiencies, there could
be material misstatements in our consolidated financial statements and we could fail to meet our
financial reporting obligations. As a result, our ability to obtain additional financing, or
obtain additional financing on favorable terms, could be materially and adversely affected, which,
in turn, could materially and adversely affect our business, our financial condition and the market
value of our securities. In addition, perceptions of us could also be adversely affected among
customers, lenders, investors, securities analysts and others. Current material weaknesses or any
future weaknesses or deficiencies could also hurt confidence in our business and consolidated
financial statements and our ability to do business with these groups.
Our revenue recognition policy has changed to the sell-through method which is currently not used
by most companies in the pharmaceutical industry which will make it more difficult to compare our
results to the results of our competitors.
Because our revenue recognition policy has changed to the sell-through method which reflects
products sold through the distribution channel, we do not recognize revenue for the domestic
product shipments of AVINZA, ONTAK, Targretin capsules and Targretin gel. Under our previous
method of accounting, product sales were recognized at time of shipment.
Under the sell-through revenue recognition method, future product sales and gross margins may
be affected by the timing of certain gross to net sales adjustments including the cost of certain
services provided by wholesalers under distribution service agreements, and the impact of price
increases. Cost of products sold and therefore gross margins for our products may also be further
impacted by changes in the timing of revenue recognition. Additionally, our revenue recognition
models incorporate a significant amount of third party data from our wholesalers and IMS. Such data
is subject to estimates and as such, any changes or corrections to these estimates identified in
later periods, such as changes or corrections occurring as a result of natural disasters or other
disruptions, including Hurricane Katrina, could affect the revenue that we report in future
periods.
As a result of our change in revenue recognition policy and the fact that the sell-through
method is not widely used by our competitors, it may be difficult for potential and current
stockholders to assess our financial results and compare these results to others in our industry.
This may have an adverse effect on our stock price.
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Our new revenue recognition models under the sell-through method are extremely complex and depend
upon the accuracy and consistency of third party data as well as dependence upon key finance and
accounting personnel to maintain and implement the controls surrounding such models.
We have developed revenue recognition models under the sell-through method that are unique to
the Companys business and therefore are highly complex and not widely used in the pharmaceutical
industry. The revenue recognition models incorporate a significant amount of third-party data from
our wholesalers and IMS. To effectively maintain the revenue recognition models, we depend to a
considerable degree upon the timely and accurate reporting to us of such data from these third
parties and our key accounting and finance personnel to accurately interpolate such data into the
models. If the third-party data is not calculated on a consistent basis and reported to us on an
accurate or timely basis or we lose any of our key accounting and finance personnel, the accuracy
of our consolidated financial statements could be materially affected. This could cause future
delays in our earnings announcements, regulatory filings with the SEC, and potential delays in
relisting or delisting with the NASDAQ.
Our common stock was delisted from the NASDAQ National Market which may reduce the price of our
common stock and the levels of liquidity available to our stockholders and cause confusion among
investors.
Our common stock was delisted from the NASDAQ National Market on September 7, 2005. Unless
and until the Companys common stock is relisted on NASDAQ, its common stock is expected to be
quoted on the Pink Sheets. The quotation of our common stock on the Pink Sheets may reduce the
price of our common stock and the levels of liquidity available to our stockholders. In addition,
the quotation of our common stock on the Pink Sheets may materially adversely affect our access to
the capital markets, and any limitation on liquidity or reduction in the price of our common stock
could materially adversely affect our ability to raise capital through alternative financing
sources on terms acceptable to us or at all. Stocks that are quoted on the Pink Sheets are no
longer eligible for margin loans, and a company quoted on the Pink Sheets cannot avail itself of
federal preemption of state securities or blue sky laws, which adds substantial compliance costs
to securities issuances, including pursuant to employee option plans, stock purchase plans and
private or public offerings of securities. Our delisting from the NASDAQ National Market and
quotation on the Pink Sheets may also result in other negative implications, including the
potential loss of confidence by suppliers, customers and employees, the loss of institutional
investor interest and fewer business development opportunities.
While we intend to apply to have our common stock relisted on the NASDAQ National Market when
we regain compliance with the listing standards, we may not be successful in that effort. Even if
we are successful in getting our common stock relisted on NASDAQ, the relisting may cause confusion
among investors who have become accustomed to our being quoted on the Pink Sheets as they seek to
determine our stock price or trade in our stock.
Our small number of products and our dependence on partners and other third parties means our
results are vulnerable to setbacks with respect to any one product.
We currently have only five products approved for marketing and a handful of other
products/indications that have made significant progress through development. Because these numbers
are small, especially the number of marketed products, any significant setback with respect to any
one of them could significantly impair our operating results and/or reduce the market prices for
our securities. Setbacks could include problems with shipping, distribution, manufacturing, product
safety, marketing, government licenses and approvals, intellectual property rights and physician or
patient acceptance of the product, as well as higher than expected total rebates, returns or
discounts.
In particular, AVINZA, our pain product, now accounts for a majority of our product revenues
and we expect AVINZA revenues will continue to grow over the next several years. Thus any setback
with respect to AVINZA could significantly impact our financial results and our share price.
AVINZA was licensed from Elan Corporation which is currently its sole manufacturer. We have
contracted with Cardinal to provide additional manufacturing capacity and second source back-up,
however we expect Elan will 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.
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Similarly, our co-promotion partner executes a large part of the marketing and sales efforts
for AVINZA and those efforts may be affected by our partners organization, operations, activities
and events both related and unrelated to AVINZA. Our co-promotion efforts have encountered and
continue to encounter a number of difficulties, uncertainties and challenges, including sales force
reorganizations and lower than expected sales call and prescription volumes, which have hurt and
could continue to hurt AVINZA sales growth. The negative impact on the products sales growth in
turn has caused and may continue to cause our revenues and earnings to be disappointing. Any
failure to fully optimize this co-promotion arrangement and the AVINZA brand, by either partner,
could also cause AVINZA sales and our financial results to be disappointing and hurt our stock
price. Any disputes with our co-promotion partner over these or other issues could harm the
promotion and sales of AVINZA and could result in substantial costs to us.
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 are in the process of making appropriate changes to the
label. The FDA also requested clinical studies to investigate the risks associated with taking
AVINZA with alcohol. We are in discussions with the FDA regarding the design of those studies.
These additional warnings, studies and any further regulatory action could have significant adverse
affects on AVINZA sales.
Our product development and commercialization involves a number of uncertainties, and we may never
generate sufficient revenues from the sale of products to become profitable.
We were founded in 1987. We have incurred significant losses since our inception. At June 30,
2005, our accumulated deficit was approximately $822.1 million. We began receiving revenues from
the sale of pharmaceutical products in 1999. We achieved quarterly net income of $17.3 million
during the fourth quarter of 2004, which was primarily the result of recognizing approximately
$31.3 million from the sale of royalty rights to Royalty Pharma. However, for the three and six
months ended June 30, 2005, we incurred a net loss of $8.9 and $27.4 million, respectively, and
expect to incur net losses in future quarters. 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.
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.
We are building marketing and sales capabilities in the United States and Europe which is an
expensive and time-consuming process and may increase our operating losses.
Developing the sales force to market and sell products is a difficult, expensive and
time-consuming process. We have developed a US sales force of approximately 140 people. 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, any revenues we receive will
depend substantially on the marketing and sales efforts of others, which may or may not be
successful.
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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 150 locations throughout the United States.
The purchasing and stocking patterns of our wholesaler customers for all our products are
influenced by a number of factors that vary from product to product, including but not limited to
overall level of demand, periodic promotions, required minimum shipping quantities and wholesaler
competitive initiatives. As a result, the overall level of product in the distribution channel may
average from two to six months worth of projected inventory usage. Although we have distribution
services contracts in place to maintain stable inventories at our major wholesalers, if any of them
were to substantially reduce the inventory they carry in a given period, e.g. due to circumstances
beyond their reasonable control, or contract termination or expiration, our shipments and cash flow
for that period could be substantially lower than historical levels.
In the second half of 2004, we entered into new 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:
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conduct research, preclinical testing and human studies; |
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establish and develop quality control, regulatory, marketing, sales and administrative capabilities to support these
programs. |
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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 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 $200 million and $275 million. However, we base our outlook regarding the need for funds on
many uncertain variables. Such uncertainties include regulatory approvals, the timing of events
outside our direct control such as product launches by partners and the success of such product
launches, negotiations with potential strategic partners and other factors. Any of these uncertain
events can significantly change our cash requirements as they determine such one-time events as the
receipt of major milestones and other payments.
While we expect to fund our research and development activities from cash generated from
internal operations to the extent possible, if we are unable to do so we may need to complete
additional equity or debt financings or seek other external means of financing. If additional funds
are required to support our operations and we are unable to obtain them on terms favorable to us,
we may be required to cease or reduce further development or commercialization of our products, to
sell some or all of our technology or assets or to merge with another entity.
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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 a private placement. 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.
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, the most
significant of which are our Phase III trials for Targretin capsules in NSCLC, lasofoxifene which
is under NDA review 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 analysis completed after the initial intent to treat
results are being analyzed. We have been evaluating data from current and prior Phase II studies to
see if they show a similar correlation between hypertriglyceridemia and increased survival. The
data will further shape our future plans for Targretin. If further studies are justified they will
be conducted on our own or with a partner or cooperative group. These analyses may not be favorable
and may not be completed or demonstrate any hypothesis or endpoint. If these analyses or subsequent
data fails to show safety or effectiveness, our stock price could be harmed. In addition,
subsequent data may be inconclusive or mixed and could be delayed. The FDA may not approve
Targretin for this new indication, or may delay approval, even if the data appears to be favorable.
Any of these events could depress our stock price.
The rate at which we complete our clinical trials depends on many factors, including our
ability to obtain adequate supplies of the products to be tested and patient enrollment. Patient
enrollment is a function of many factors, including the size of the patient population, the
proximity of patients to clinical sites and the eligibility criteria for the trial. For example,
each of our Phase III Targretin clinical trials involved approximately 600 patients and required
significant time and investment to complete enrollments. Delays in patient enrollment for our other
trials may result in increased costs and longer development times. In addition, our collaborative
partners have rights to control product development and clinical programs for products developed
under the collaborations. As a result, these collaborators may conduct these programs more slowly
or in a different manner than we had expected. Even if
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clinical trials are completed, we or our
collaborative partners still may not apply for FDA approval in a timely manner or the FDA still may
not grant approval.
We face substantial competition which may limit our revenues.
Some of the drugs that we are developing and marketing will compete with existing treatments.
In addition, several companies are developing new drugs that target the same diseases that we are
targeting and are taking IR-related and STAT-related approaches to drug development. The principal
products competing with our products targeted at the cutaneous t-cell lymphoma market are
Supergen/Abbotts Nipent and interferon, which is marketed by a number of companies, including
Schering-Ploughs Intron A. Products that compete with AVINZA include Purdue Pharma L.P.s
OxyContin and MS Contin and potentially Palladone (launched in early 2005 and subsequently
withdrawn from the market), Janssen Pharmaceutica Products, 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 us 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.
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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.
65
Hoffmann-La Roche Inc. has received a US patent, has made patent filings and has issued
patents in foreign countries that relate to our Panretin gel products. While we were unsuccessful
in having certain claims of the US patent awarded to Ligand in interference proceedings, we
continue to believe that any relevant claims in these Hoffman-La Roche patents in relevant
jurisdictions are invalid and that our current commercial activities and plans relating to Panretin
are not covered by these Hoffman-La Roche patents in the US or elsewhere. In addition, we have our
own portfolio of issued and pending patents in this area which cover our commercial activities, as
well as other uses of 9-cis retinoic acid, in the US, Europe and elsewhere. However, if the claims
in these Hoffman-La Roche patents are not invalid and/or unenforceable, they might block the use of
Panretin gel in specified cancers, not currently under active development or commercialization by
us.
Novartis AG has filed an opposition to our European patent that covers the principal active
ingredient of our ONTAK drug. We have received a favorable preliminary opinion from the European
Patent Office, however this is not a final determination and Novartis has filed a response to the
preliminary opinion that argues our patent is invalid. If the opposition is successful, we could
lose our ONTAK patent protection in Europe which could substantially reduce our future ONTAK sales
in that region. We could also incur substantial costs in asserting our rights in this opposition
proceeding, as well as in other possible future proceedings in the United States.
We also rely on unpatented trade secrets and know-how to protect and maintain our competitive
position. We require our employees, consultants, collaborators and others to sign confidentiality
agreements when they begin their relationship with us. These agreements may be breached, and we may
not have adequate remedies for any breach. In addition, our competitors may independently discover
our trade secrets.
Reliance on third-party manufacturers to supply our products risks supply interruption or
contamination and difficulty controlling costs.
We currently have no manufacturing facilities, and we rely on others for clinical or
commercial production of our marketed and potential products. In addition, some raw materials
necessary for the commercial manufacturing of our products are custom and must be obtained from a
specific sole source. Elan manufactures AVINZA for us, Cambrex manufactures ONTAK active
pharmaceutical ingredient for us, Raylo manufacture Targretin active pharmaceutical ingredient for
us, and Cardinal Health manufactures Targretin capsules for us. We also recently entered into
contracts with Cardinal Health to manufacture and package AVINZA and with Hollister-Stier for the
filling and finishing of ONTAK. Each of these recent contracts calls for manufacturing and
packaging the product at a new facility. Qualification and regulatory approval for these
facilities are required prior to starting commercial manufacturing and was recently received in
2005 for both facilities. Any delays or failures of the manufacturing or packaging process could
cause inventory problems or product shortages.
To be successful, we will need to ensure continuity of the manufacture of our products, either
directly or through others, in commercial quantities, in compliance with regulatory requirements at
acceptable cost and in sufficient quantities to meet product growth demands. Any extended or
unplanned manufacturing shutdowns, shortfalls or delays could be expensive and could result in
inventory and product shortages. If we are unable to reliably manufacture our products our revenues
could be adversely affected. In addition, if we are unable to supply products in development, our
ability to conduct preclinical testing and human clinical trials will be adversely affected. This
in turn could also delay our submission of products for regulatory approval and our initiation of
new development programs. In addition, although other companies have manufactured drugs acting
through IRs and STATs on a commercial scale, we may not be able to translate our core technologies
or other technologies into drugs that can be manufactured at costs or in quantities to make
marketable products.
The manufacturing process also may be susceptible to contamination, which could cause the
affected manufacturing facility to close until the contamination is identified and fixed. In
addition, problems with equipment failure or operator error also could cause delays in filling our
customers orders.
66
Our business exposes us to product liability risks or our products may need to be recalled, and we
may not have sufficient insurance to cover any claims.
Our business exposes us to potential product liability risks. Our products also may need to be
recalled to address regulatory issues. A successful product liability claim or series of claims
brought against us could result in payment of significant amounts of money and divert managements
attention from running the business. Some of the compounds we are investigating may be harmful to
humans. For example, retinoids as a class are known to contain compounds which can cause birth
defects. We may not be able to maintain our insurance on acceptable terms, or our insurance may not
provide adequate protection in the case of a product liability claim. To the extent that product
liability insurance, if available, does not cover potential claims, we will be required to
self-insure the risks associated with such claims. We believe that we carry reasonably adequate
insurance for product liability claims.
We use hazardous materials which requires us to incur substantial costs to comply with
environmental regulations.
In connection with our research and development activities, we handle hazardous materials,
chemicals and various radioactive compounds. To properly dispose of these hazardous materials in
compliance with environmental regulations, we are required to contract with third parties at
substantial cost to us. Our annual cost of compliance with these regulations is approximately
$700,000. 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.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
During the quarter ended June 30, 2005 an aggregate of, approximately 31,000 shares of our
common stock were issued to a director and a consultant of the Company in connection with certain
option exercises under the Companys 2002 option plan (the 2002 option plan). The Company
received approximately $186,000 from the option exercises. The 2002 option plan was registered by
the Company on a Form S-8. However, due to a delay in the Companys periodic report filings, the
Form S-8 was not current at the time the shares were issued. Each of the recipients that was
issued shares under the 2002 option plan is an accredited investor in accordance with Rule 501 of
Regulation D.
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ITEM 6. EXHIBITS
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|
|
Exhibit Number |
|
Description |
|
3.1 (1)
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Amended and Restated Certificate of Incorporation of the Company. (Filed as
Exhibit 3.2). |
3.2 (1)
|
|
Bylaws of the Company, as amended. (Filed as Exhibit 3.3). |
3.3 (2)
|
|
Amended Certificate of Designation of Rights, Preferences and Privileges of
Series A Participating Preferred Stock of the Company. |
3.5 (3)
|
|
Certificate of Amendment of the Amended and Restated Certificate of
Incorporation of the Company dated June 14, 2000. |
3.6 (4)
|
|
Certificate of Amendment of the Amended and Restated Certificate of
Incorporation of the Company dated September 30, 2004. |
4.1 (5)
|
|
Specimen stock certificate for shares of Common Stock of the Company. |
4.2 (6)
|
|
Preferred Shares Rights Agreement, dated as of September 13, 1996, by and
between the Company and Wells Fargo Bank, N.A. (Filed as Exhibit 10.1). |
4.3 (7)
|
|
Amendment to Preferred Shares Rights Agreement, dated as of November 9, 1998,
between the Company and ChaseMellon Shareholder Services, L.L.C., as Rights
Agent. (Filed as Exhibit 99.1). |
4.4 (8)
|
|
Second Amendment to the Preferred Shares Rights Agreement, dated as of December
23, 1998, between the Company and ChaseMellon Shareholder Services, L.L.C., as
Rights Agent (Filed as Exhibit 1). |
4.7 (9)
|
|
Fourth Amendment to the Preferred Shares Rights Agreement and Certification of
Compliance with Section 27 Thereof, dated as of October 3, 2002, between the
Company and Mellon Investor Services LLC, as Rights Agent. |
4.9 (10)
|
|
Indenture dated November 26, 2002, between Ligand Pharmaceuticals Incorporated
and J.P. Morgan Trust Company, National Association, as trustee, with respect
to the 6% convertible subordinated notes due 2007. (Filed as Exhibit 4.3). |
4.10 (10)
|
|
Form of 6% Convertible Subordinated Note due 2007. (Filed as Exhibit 4.4). |
4.11 (10)
|
|
Pledge Agreement dated November 26, 2002, between Ligand Pharmaceuticals
Incorporated and J.P. Morgan Trust Company, National Association. (Filed as
Exhibit 4.5). |
4.12 (10)
|
|
Control Agreement dated November 26, 2002, among Ligand Pharmaceuticals
Incorporated, J.P. Morgan Trust Company, National Association and JP Morgan
Chase Bank. (Filed as Exhibit 4.6). |
4.13 (11)
|
|
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. |
31.1
|
|
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. |
31.2
|
|
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. |
32.1
|
|
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. |
32.2
|
|
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. |
68
|
|
|
(1) |
|
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. |
|
(2) |
|
This exhibit was previously filed as part of and is hereby incorporated by reference to same
numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period ended
March 31, 1999. |
|
(3) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 2000. |
|
(4) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2004. |
|
(5) |
|
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. |
|
(6) |
|
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. |
|
(7) |
|
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. |
|
(8) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Registration Statement on Form 8-A/A Amendment No. 2 (No.
0-20720) filed on December 24, 1998. |
|
(9) |
|
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. |
|
(10) |
|
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. |
|
(11) |
|
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. |
69
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: December 9, 2005 |
By: |
/s/ Paul V. Maier
|
|
|
|
Paul V. Maier |
|
|
|
Senior Vice President, Chief Financial Officer |
|
70