Ligand Announces Preliminary Revenue Estimates For Third Quarter of Fiscal 2005, Preliminary Results for First and Second Quarters of Fiscal 2005 and Filing of 10-K and Audited Results for Fiscal 2004, 2003, and 2002.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- Ligand ligand (lĭg`ənd), charged or uncharged molecule with one or more unshared pairs of electrons that can attach to a central metallic atom or ion to form an aggregate known as a complex ion (see chemical bond). Pharmaceuticals Incorporated (Pink Sheets:LGND LGND Luminance Ground ) today announced preliminary revenue estimates for its third quarter of fiscal year 2005 and preliminary financial results for its first and second quarters of fiscal year 2005. The company also announced that the Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for fiscal year 2004 containing audited results for fiscal 2004, restated audited results for fiscal years 2003 and 2002, and a restatement Restatement A revision in a company's earlier financial statements. Notes: The need for restating financial figures can result from fraud, misrepresentation, or a simple clerical error. of selected financial data for fiscal years 2001 and 2000 has been filed today with the Securities and Exchange Commission (SEC). The company's independent public accounting firm, BDO Seidman BDO Seidman, LLP is the United States arm of BDO International, one of the largest accounting firms outside of the Big Four. History BDO Seidman, LLP was founded as Seidman and Seidman in New York City in 1910 by Maximillian L. Seidman. , LLP LLP - Lower Layer Protocol ("BDO BDO Big Day Out (Australian music festival) BDO Banco de Oro (Philippines) BDO 1,4-Butanediol BDO British Darts Organisation BDO Block Development Officer BDO Big Dumb Object "), has not completed its review of the financial results for the first, second or third quarters, including the quarterly preliminary revenue estimates for the third quarter of 2005 provided in this press release. The 2005 financial data and discussions presented in this press release are preliminary, unaudited and unreviewed by the company's independent public accountants. Consequently, they should be viewed as reflecting the company's current expectations with due regard to items still to be completed as discussed elsewhere in this press release. Since the completion and review of 2005 quarterly financial data is still ongoing and BDO's review of those periods is ongoing, the 2005 financial information provided in this press release is subject to change and the changes, individually or in the aggregate, may be material to the company's financial position, results of operation or liquidity. "We are pleased to announce the completion and filing of our Form 10-K for the fiscal year ended December December: see month. 31, 2004 which includes the restated audited results for fiscal years 2003 and 2002 and a restatement of selected financial data for fiscal years 2001 and 2000 as well as release of preliminary results for our first and second quarters and preliminary revenue estimates for the third quarter of this year," said David E. Robinson, Chairman, President and Chief Executive Officer of Ligand Pharmaceuticals. "We expect to complete the rest of the financial reporting normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record. process by filing our first, second and third quarter Form 10-Qs Form 10-Q See 10-Q. by early December as well as to submit our application for relisting of our common stock on the NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on National Market after all required filings are made with the SEC." "The board of directors, audit committee, and management recognize that this complicated and time-consuming time-con·sum·ing adj. Taking up much time. time-consuming Adjective taking up a great deal of time Adj. 1. process has been challenging to all stakeholders Stakeholders All parties that have an interest, financial or otherwise, in a firm-stockholders, creditors, bondholders, employees, customers, management, the community, and the government. and very much appreciate the patience Patience, poem Patience: see Pearl, The. patience, card game patience: see solitaire. Patience See also Longsuffering. and support demonstrated to the company while it is completing this process. We look forward to resuming a robust dialogue with all shareholders on the business and financial profile of the company in the coming days and weeks and to respond to questions consistent with the updated information included in our SEC filings and this press release," said Robinson. "We are also confirming that our delayed annual shareholder meeting is scheduled to be held January January: see month. 31, 2006. I would like to express my deep appreciation for the many dedicated, hard-working hard-working adj → trabajador(a) hard-working hard adj → travailleur/euse, consciencieux/euse hard-working hard , professional employees, consultants, and advisors without whom the completion of this milestone “Milemarker” redirects here. For the American indie rock band, see Milemarker (band). A milestone or kilometre sign is one of a series of numbered markers placed along a road at regular intervals, typically at the side of the road or in a median. would have been impossible," Robinson said. "We note that the company has received an unqualified opinion Unqualified opinion An independent auditor's opinion that a company's financial statements comply with accepted accounting procedures. Antithesis of qualified opinion. unqualified opinion See clean opinion. from its independent public accounting firm on the consolidated balance sheets consolidated balance sheet A balance sheet in which assets and liabilities of a parent company and its controlled subsidiaries are combined, thereby presenting balance sheet items for the parent and its subsidiaries as if they were a single firm. as of December 31, 2004 and 2003 and the results of operations and cash flows for each of the three years in the period ended December 31, 2004. But we are mindful mind·ful adj. Attentive; heedful: always mindful of family responsibilities. See Synonyms at careful. mind as well that while the company received an unqualified opinion on management's assessment of internal control over financial reporting, we also received an adverse opinion from our independent public accounting firm on the effectiveness of our internal control over financial reporting as of December 31, 2004. As a result, we take as a top priority the importance of implementing the robust plan of remediation as outlined in our Form 10-K and have implemented since December 31, 2004 or are in the process of implementing the actions included in that remediation plan." Preliminary Revenue Estimates for Third Quarter of Fiscal 2005 Show Strong Growth Over Prior Year Summary: The following information summarizes the preliminary revenue estimates for the third quarter of fiscal year 2005 and, as previously noted, should be viewed with due regard to the ongoing process in which the company and its independent public accountants are engaged. BDO has not completed its review of the financial results for the first, second or third quarters, including the quarterly preliminary revenue estimates for the third quarter of 2005 provided in this press release. As noted above, the 2005 financial information provided in this press release is subject to changes, which individually or in the aggregate, may be material to the company's financial position, results of operation or liquidity. Total revenues for the third quarter of 2005 under the new sell-through sell-through Adjective of the sale of prerecorded video cassettes, without their first being for hire only revenue recognition methodology are estimated to be $44.8 million and are expected to consist of $42.6 million of net product sales, a growth of 34% compared to the third quarter of 2004, and $2.2 million of collaborative col·lab·o·rate intr.v. col·lab·o·rat·ed, col·lab·o·rat·ing, col·lab·o·rates 1. To work together, especially in a joint intellectual effort. 2. research and development and other revenues. The company expects to report that cash, cash equivalents, short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments and restricted investments as of September September: see month. 30, 2005 totaled approximately ap·prox·i·mate adj. 1. Almost exact or correct: the approximate time of the accident. 2. $75.6 million compared to $70.1 million at the end of the second quarter of 2005 and that net cash from operations for the third quarter was positive. The table below shows preliminary net product sales by product (in millions) for the third quarter of 2005 compared to unaudited restated net product sales for the third quarter of fiscal year 2004:
Three months ended September 30,
--------------------------------------
2005 2004
(Preliminary) (Restated)
------------------ -------------------
AVINZA(R) $29.9 $20.0
ONTAK(R) 7.4 7.0
Targretin(R) capsules 4.4 3.9
Targretin(R) & Panretin(R) gels 0.9 1.0
------------------ -------------------
Total product sales $42.6 $31.9
================== ===================
The company intends to complete its work on the third quarter financial statements, including support work to the BDO review, so that a filing can be made in early December 2005. Upon filing of its third quarter Form 10-Q, the company expects to be current in its SEC filings, thus enabling the company to submit its application for relisting of its common stock on the NASDAQ National Market. Preliminary Results for Second and First Quarters of Fiscal 2005 Show Strong Revenue Growth and Reduction in Net Losses Versus Prior Year The numbers presented in this press release for the first and second quarters of fiscal year 2005 should be viewed with due regard to the ongoing process in which the company and its independent public accountants are engaged. BDO has not completed its review of the financial results for the first, second or third quarters, including the quarterly preliminary revenue estimates for the third quarter of 2005 provided in this press release. As noted above, the 2005 financial information provided in this press release is subject to changes, which individually or in the aggregate, may be material to the company's financial position, results of operation or liquidity. Three and Six Months Ended June June: see month. 30, 2005 as compared to June 30, 2004 Summary: Total revenues for the three months ended June 30, 2005 were $45.8 million compared to $32.3 million for the same 2004 period, an increase of 42%. Loss from operations was $5.8 million for the three months ended June 30, 2005 compared to $19.1 million for the same 2004 period, a decrease of 70%. Net loss for the three months ended June 30, 2005 was $8.2 million ($0.11 per share) compared to $22.1 million ($0.30 per share) for the same 2004 period, representing a decrease of 63%. Total revenues for the six months ended June 30, 2005 were $82.8 million compared to $59.7 million for the same 2004 period, an increase of 39%. Loss from operations was $20.5 million for the six months ended June 30, 2005 compared to $38.2 million for the same 2004 period, a decrease of 46%. Net loss for the six months ended June 30, 2005 was $25.6 million ($0.35 per share) compared to $44.0 million ($0.60 per share) for the same 2004 period, representing a decrease of 42%. "Ligand's strong product sales growth of 42% in the second quarter of 2005 compared to the same period in 2004 reflects the nearly doubling of AVINZA(R) sales to $27.5 million and market share growth to 4.5%," said Paul V Paul V, 1552–1621, pope (1605–21), a Roman named Camillo Borghese; successor of Leo XI. He was created cardinal (1596) by Clement VIII and was renowned for his knowledge of canon law. . Maier Maier is a surname, and may refer to:
The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. compared to the prior year contributed to the reduction of quarterly operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. to $5.8 million, an improvement sequentially se·quen·tial adj. 1. Forming or characterized by a sequence, as of units or musical notes. 2. Sequent. se·quen and compared to the prior year. In addition, the company ended the second quarter 2005 with $70.1 million in cash, cash equivalents, short-term investments and restricted investments after completing the ONTAK(R) royalty Compensation for the use of property, usually copyrighted works, patented inventions, or natural resources, expressed as a percentage of receipts from using the property or as a payment for each unit produced. buy-down with Lilly For lily, the flower, see . Lilly is a surname and a female given name, and may refer to: People
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share data)
Three Months Ended Six Months Ended
June 30, June 30,
----------------------- -----------------------
2005 2004 2005 2004
(Restated) (Restated)
----------- ----------- ----------- -----------
Revenues:
Product sales $41,735 $29,299 $76,780 $54,238
Collaborative
research and
development and
other revenues 4,064 2,975 6,004 5,451
----------- ----------- ----------- -----------
Total
revenues 45,799 32,274 82,784 59,689
----------- ----------- ----------- -----------
Operating costs and
expenses:
Cost of products
sold 10,555 9,718 21,238 17,263
Research and
development 13,120 16,566 26,761 34,083
Selling, general and
administrative 20,910 18,116 40,582 32,821
Co-promotion 6,966 7,000 14,706 13,731
----------- ----------- ----------- -----------
Total
operating
costs and
expenses 51,551 51,400 103,287 97,898
----------- ----------- ----------- -----------
Loss from operations (5,752) (19,126) (20,503) (38,209)
Other expense, net (2,417) (2,939) (5,119) (5,768)
----------- ----------- ----------- -----------
Net loss $(8,169) $(22,065) $(25,622) $(43,977)
=========== =========== =========== ===========
Basic and diluted per
share amounts:
Net loss $(0.11) $(0.30) $(0.35) $(0.60)
=========== =========== =========== ===========
Weighted average
number of common
shares 74,036,753 73,754,146 73,976,939 73,528,581
=========== =========== =========== ===========
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share data)
Three Months Ended
March 31,
-----------------------
2005 2004
(Restated)
----------- -----------
Revenues:
Product Sales $35,045 $24,939
Collaborative research and development and
other revenues 1,940 2,476
----------- -----------
Total revenues 36,985 27,415
----------- -----------
Operating costs and expenses:
Cost of products sold 10,683 7,545
Research and development 13,641 17,517
Selling, general and administrative 19,672 14,705
Co-promotion 7,740 6,731
----------- -----------
Total operating costs and expenses 51,736 46,498
----------- -----------
Loss from operations (14,751) (19,083)
Other expense, net (2,702) (2,829)
----------- -----------
Net loss $(17,453) $(21,912)
=========== ===========
Basic and diluted per share amounts:
Net loss $(0.24) $(0.30)
=========== ===========
Weighted average number of common shares 73,916,470 73,299,281
=========== ===========
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands)
June 30, March 31, December
2005 2005 31, 2004
--------- --------- ---------
Assets
Current assets:
Cash, cash equivalents and short-term
investments $68,274 $89,405 $112,492
Other current assets 50,057 48,698 60,332
--------- --------- ---------
Total current assets 118,331 138,103 172,824
Restricted investments 1,826 1,656 2,378
Property and equipment, net 22,927 23,275 23,647
Acquired technology and product rights,
net 153,773 144,275 127,443
Other assets 6,490 6,888 6,174
--------- --------- ---------
$303,347 $314,197 $332,466
========= ========= =========
Liabilities and Stockholders' Deficit
Current liabilities, excluding deferred
revenue $59,959 $63,203 $64,184
Current portion of deferred revenue, net 153,372 152,938 152,528
Long-term debt 166,919 167,002 167,089
Other long-term liabilities 11,368 11,646 11,637
Common stock subject to conditional
redemption 12,345 12,345 12,345
Stockholders' deficit (100,616) (92,937) (75,317)
--------- --------- ---------
$303,347 $314,197 $332,466
========= ========= =========
Total Net Product Sales: 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, an increase of 42%. 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, an increase of 42%. A comparison of total net product sales by product is as follows (in thousands):
Three months ended Six months ended
June 30, June 30,
------------------- -------------------
2005 2004 2005 2004
(Restated) (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 & Panretin gels 824 1,020 1,833 1,954
-------- ---------- -------- ----------
Total net product sales $41,735 $29,299 $76,780 $54,238
======== ========== ======== ==========
The increase in sales of AVINZA to $27.5 million for the three months ended June 30, 2005 compared to $14.2 million for the same 2004 period is due to higher prescriptions as a result of the increased level of marketing and sales activity, impact of price increases in 2004, a prescription prescription In property law, the effect of the lapse of time in creating and destroying rights. Acquisitive prescription allows an individual, after unequivocal possession for a specific period, to acquire an interest in real property, such as an easement, but not the mix shift to higher doses and the product's growth in state Medicaid Medicaid, national health insurance program in the United States for low-income persons; established in 1965 with passage of the Social Security Amendments and now run by the Centers for Medicare and Medicaid Services. and commercial formulary formulary /for·mu·lary/ (for´mu-lar?e) a collection of recipes, formulas, and prescriptions. National Formulary see under N. for·mu·lar·y n. contracts. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. 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 period in 2004. The decrease in sales of ONTAK for the three and six months ended June 30, 2005 compared to the same periods in 2004 reflects a 12% and 4% decrease in wholesale out-movement, respectively. Such decreases are primarily due to a decline in the office segment of the market which has been impacted by reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. rates. Increases in the hospital segment have not been sufficient to offset the office segment trend. ONTAK sales were also negatively impacted by a continued increase in chargebacks and rebates due to changes in patient mix and evolving reimbursement rates including disproportionate share hospitals The United States government provides special funding to hospitals who treat significant populations of indigent patients through the Disproportionate Share Hospital (DSH) programs. (DSH DSH Disproportionate Share Hospital DSH Domestic Short Hair (cat) DSH Deliberate Self-Harm DSH Desperately Seeking Help (USENET) DSH Dyschromatosis Symmetrica Hereditaria ). We expect that sales of ONTAK will continue to be negatively impacted by changes to the Center for Medicare and Medicaid Medicare and Medicaid U.S. government programs in effect since 1966. Medicare covers most people 65 or older and those with long-term disabilities. Part A, a hospital insurance plan, also pays for home health visits and hospice care. Services reimbursement rates for 2005 but expect improved reimbursement rates based on most recent ASP asp, popular name for several species of viper, one of which, the European asp (Vipera aspis), is native to S Europe. It is also a name for the Egyptian cobra (Naja haja). filings moving into 2006. Sales of Targretin(R) capsules increased during the periods as a result of the impact of a price increase, a U.S. demand increase as reported by IMS Health IMS Health (NYSE: RX) is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. (as measured by product out-movement) and increased penetration The successful unauthorized breach of a security perimeter. See penetration test. in the European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. markets where unit sales unit sales Sales measured in terms of physical units rather than dollars. Unit sales data are often used by financial analysts when evaluating the health of a company. grew 21% in the second quarter 2005 over the same period in the prior year. Gross Margin: Gross margin on product sales was 74.7% 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 72.3% compared to 68.2% for the same 2004 period. Overall, given the fixed level of amortization of the capitalized Capitalized Recorded in asset accounts and then depreciated or amortized, as is appropriate for expenditures for items with useful lives longer than one year. 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 restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). of the ONTAK royalty agreement. The increase in gross 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 Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible 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 November: see month. 2002. ONTAK margins were also positively impacted during the three and six months ended June 30, 2005 by lower royalties Not to be confused with Royal family. Royalties (sometimes, running royalties) are usage-based payments made by one party (the "licensee") to another (the "licensor") for ongoing use of an asset, most typically an intellectual property (IP) right. as a result of the partial impact of the restructuring of the company's royalty obligation to Lilly, which resulted in no royalty liability owed to Lilly for the three and six months ended June 30, 2005. This impact was partially offset by $1.3 million of amortization for the six months ended June 30, 2005 of the $33.0 million paid to Lilly to restructure the ONTAK royalty and the recognition of $2.6 million 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. Gross margins for the three and six months ended June 30, 2005 were also favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. impacted by price increases on ONTAK, Targretin capsules and Targretin gel which became effective January 1, 2004 and for AVINZA which became effective July July: see month. 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 margins for the three and six months ended June 30, 2005 compared to the same 2004 period were negatively impacted, however, by a higher proportionate pro·por·tion·ate adj. Being in due proportion; proportional. tr.v. pro·por·tion·at·ed, pro·por·tion·at·ing, pro·por·tion·ates To make proportionate. level of AVINZA rebates and ONTAK chargebacks and rebates and the fixed costs fixed costs, n.pl the costs that do not change to meet fluctuations in enrollment or in use of services (e.g., salaries, rent, business license fees, and depreciation). associated with our wholesaler distribution service agreements. Collaborative R&D/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. R&D: Research and development expenses were $13.1 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 $26.8 million compared to $34.1 million for the same 2004 period. The reduction in research and development expenses in both periods of 2005 compared to 2004 principally reflects lower development costs due to completion of the SPIRIT I and II trials. SG&A: Selling, general and administrative expenses were $20.9 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 $40.6 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 restatement of the company's 2003 and 2002 consolidated financial statements Consolidated Financial Statements The combined financial statements of a parent company and its subsidiaries. Notes: Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge , the costs of using outside consultants to assist in the restatement process and development of the new revenue recognition models, and ongoing shareholder litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . Selling, general and administrative expenses are expected to further increase in 2005 due to the full year impact of hiring of an additional 36 pain specialist sales representatives and due to significantly higher accounting and legal expenses incurred in connection with the restatement of our consolidated financial statements, SEC investigation and shareholder litigation. Co-promotion Co-promotion is a marketing practice where a company in addition to its own, uses another company's sales force to promote the same brand or range of brands. The term is frequently confused with Co-marketing. See also Marketing co-operation : Co-promotion expense under our co-promotion arrangement with Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. 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. Co-promotion expense is based on net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of AVINZA which totaled $27.5 million for the three months ended June 30, 2005 compared to $14.2 million for the same 2004 period. In the six months ended June 30, 2005, AVINZA sales totaled $49.5 million compared to $27.5 million for the same 2004 period. We pay Organon, under the terms of our co-promotion agreement, 30% of net AVINZA sales, determined in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (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 period was determined based upon the company's shipments of AVINZA to wholesalers under the previously utilized sell-in revenue recognition method and therefore does not calculate at the contract agreement percentage of net sales. However, AVINZA shipments made to wholesalers did not meet the revenue recognition criteria criteria (krītēr´ē n. under GAAP and such transactions were restated under the company's standard accounting principles using the sell-through method. Because this sell-in revenue recognition method was not in accordance with GAAP, we believe that we have overpaid o·ver·pay v. o·ver·paid , o·ver·pay·ing, o·ver·pays v.tr. 1. To pay (a party) too much. 2. To pay an amount in excess of (a sum due). v.intr. To pay too much. Organon under the terms of the agreement by approximately $11.5 million through June 30, 2005. We have notified Organon regarding the overpayment o·ver·pay v. o·ver·paid , o·ver·pay·ing, o·ver·pays v.tr. 1. To pay (a party) too much. 2. To pay an amount in excess of (a sum due). v.intr. To pay too much. and our intent to apply such overpayment to future 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 as part of a dialogue on our overall relationship. The discussions continue, however the payments previously made are recorded in the company's consolidated financial statements as "co-promotion expense." Until this matter is resolved, we will continue to account for co-promotion expense based on net sales determined using the sell-in method (even though reported AVINZA net sales reflect sell-through accounting). The company intends to withhold with·hold v. with·held , with·hold·ing, with·holds v.tr. 1. To keep in check; restrain. 2. To refrain from giving, granting, or permitting. See Synonyms at keep. 3. cash payments to Organon until the cumulative overpayment has been eliminated, at which time future cash payments will be based on GAAP-reported net sales and the company's standard accounting principles. Liquidity 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. Restricted investments at June 30, 2005 consist of certificates of deposit held with a financial institution as collateral collateral (kəlăt`ərəl), something of value given or pledged as security for payment of a loan. Collateral consists usually of financial instruments, such as stocks, bonds, and negotiable paper, rather than physical goods, although under equipment financing and third-party service provider arrangements. Three Months Ended March 31, 2005 as compared to March 31, 2004 Summary: Total revenues for the three months ended March 31, 2005 were $37.0 million compared to $27.4 million for the same 2004 period, an increase of 35%. Loss from operations was $14.8 million for the three months ended March 31, 2005 compared to $19.1 million for the same 2004 period, a decrease of 23%. Net loss for the three months ended March 31, 2005 was $17.5 million ($0.24 per share) compared to $21.9 million ($0.30 per share) for the same 2004 period, a decrease of 20%. Total Net Product Sales: Our total net product sales for the three months ended March 31, 2005 were $35.0 million compared to $24.9 million for the same 2004 period, an increase of 41%. A comparison of sales by product is as follows (in thousands):
Three months ended March 31,
--------------------------------
2005 2004
(Restated)
-------------- ---------------
AVINZA $21,997 $13,277
ONTAK 8,024 7,311
Targretin capsules 4,015 3,417
Targretin & Panretin gels 1,009 934
-------------- ---------------
Total net product sales $35,045 $24,939
============== ===============
Sales of AVINZA increased to $22.0 million for the three months ended March 31, 2005 compared to $13.3 million for the same 2004 period due to higher prescriptions as a result of the increased level of marketing and sales activity under our co-promotion agreement and the product's success in achieving state Medicaid and commercial formulary status. According to IMS data, quarterly prescription market share for AVINZA for the three months ended March 31, 2005 was 4.4% compared to 3.2% for the same period in 2004. The increase in sales of ONTAK to $8.0 million for the three months ended March 31, 2005 compared to $7.3 million for the same 2004 period reflect primarily the impact of a 9% price increase effective January 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 no effect on net product sales recognized for the same 2004 period. Sales of Targretin capsules increased to $4.0 million for the three months ended March 31, 2005 compared to $3.4 million for the same 2004 period, reflecting the impact of a 7% price increase effective January 2004 (see ONTAK above) and increased penetration in the European markets where unit sales grew 66% over the same period in 2004. Gross Margin: Gross margin on product sales was 69.5% for the three months ended March 31, 2005 compared to 69.7% for the same 2004 period. AVINZA represented 62.8% of net product sales for the three months ended 2005 compared to 53.2% for the same 2004 period. ONTAK margins were also positively impacted during the three months ended March 31, 2005 by lower royalties as a result of the partial impact of the restructuring of the company's royalty obligation to Lilly. This impact was partially offset by amortization of $0.5 million in the first quarter of 2005 of the amount paid to Lilly, of $20.0 million, to restructure the ONTAK royalty and the recognition of $1.5 million deferred royalty expense previously paid to Lilly which under the sell-through revenue recognition method is recognized as the related product sales are recognized. Gross margin for the three months ended March 31, 2005 was also favorably impacted by price increases on ONTAK, Targretin capsules and Targretin gel which became effective January 1, 2004. Gross margin for the three months ended March 31, 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. Collaborative R&D/Other Revenues: Collaborative research and development and other revenues for the three months ended March 31, 2005 were $1.9 million compared to $2.5 million for the same 2004 period. The decrease for the three months ended March 31, 2005 compared to the same 2004 period is due to the completion of the final extension period in November 2004 of our research arrangement with Lilly, offset by increased development milestones paid by our corporate partners. R&D: Research and development expenses were $13.6 million for the three months ended March 31, 2005 compared to $17.5 million for the same 2004 period reflecting lower development expenses principally due to completion of Targretin Spirit I and II trials. SG&A: Selling, general and administrative expenses were $19.7 million for the three months ended March 31, 2005 compared to $14.7 million for the same 2004 period. The increase for the three months ended March 31, 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. Co-promotion: Co-promotion expense payable to Organon amounted to $7.7 million for the three months ended March 31, 2005 compared to $6.7 million for the same 2004 period. Co-promotion expense is based on net sales of AVINZA which totaled $22.0 million for the three months ended March 31, 2005 compared to $13.3 million for the same 2004 period. As discussed above, the consolidated financial statements included herein do not account for the overpayment to Organon (see prior discussion of Co-promotion above). Liquidity: Cash, cash equivalents, short-term investments, and restricted investments totaled $91.1 million at March 31, 2005 compared to $114.9 million at December 31, 2004. Years ended December 31, 2004, 2003(Restated) and 2002 (Restated) Summary: Total revenues for 2004 increased to $163.5 million compared to $81.1 million in 2003 and $71.8 million in 2002, increases of 102% and 13%, respectively. "Under the sell through method, product sales driven primarily by AVINZA grew strongly in 2003, increasing 82%, to $55.3 million. 2004 product sales increased 118% to $120.3 million," Maier stated. "We are pleased to have the financial reporting normalization process moving through this major milestone and towards completion so that we can increasingly focus our attention on the underlying business and the operational improvements necessary to improve the company's financial profile and shareholder value." Audited 2004/2003 Restated/2002 Restated The fundamental factor driving the restatement of our prior period financials is the adoption of the sell-through method of revenue recognition for the majority of our products in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Since the predominant pre·dom·i·nant adj. 1. Having greatest ascendancy, importance, influence, authority, or force. See Synonyms at dominant. 2. revenue recognition methodology currently utilized in the pharmaceutical industry remains the traditional sell-in method, there are a number of significant differences which should be noted in reviewing the company's restated results. For example, traditional sell-in accounting records shipments to wholesalers as product sales whether or not they expand retail pharmacy pharmacy, art of compounding and dispensing drugs and medication. The term is also applied to an establishment used for such purposes. Until modern times medication was prepared and dispensed by the physician himself. In the 18th cent. or wholesale stocking while sell-through does not. The biggest impact of the sell-through method is the timing of product revenue recognition. As a result, product sales are reduced and operating/net losses increase in 2002 and 2003 where there is a substantially reduced impact of the adoption of the new methodology in both 2004 and 2005. Further, cost of goods and gross margins are also affected by the timing of revenue recognition and certain related changes in accounting as a result of gross-to-net adjustments, returns, royalties paid, and the impact of fixed cost amortization. An additional factor to be noted is that changes to prices do not immediately impact net product sales and gross margins but are delayed until the products sell through the distribution channel. While the timing of revenue recognition has changed, operating cash flows Operating cash flow Earnings before depreciation minus taxes. Measures the cash generated from operations, not counting capital spending or working capital requirements. and customer payment terms of sale Terms of sale Conditions under which a firm proposes to sell its goods or services for cash or credit. are not affected by this accounting policy change. Restated product sales now reflect estimates of end-user (job) end-user - The person who uses a computer application, as opposed to those who developed or support it. The end-user may or may not know anything about computers, how they work, or what to do if something goes wrong. product demand (as measured by prescription levels for AVINZA or out-movement from the wholesalers for oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. products). Products which have been shipped to the wholesale or retail pharmacy channels and not yet consumed con·sume v. con·sumed, con·sum·ing, con·sumes v.tr. 1. To take in as food; eat or drink up. See Synonyms at eat. 2. a. are recorded on the balance sheet as deferred revenue. Cumulative deferred product revenue of $151.5 million as of December 31, 2004 is comprised of retail channel inventory of an estimated 37,000 pharmacies This article is a list of major pharmacies (also known as chemists and drugstores) by country. Australia Pharmacies in Australia are mostly independently-owned by pharmacists, often operated as franchises of retail brands offered by the three major stocking AVINZA with an average of less than two bottles per pharmacy and wholesale inventory of restated products in aggregate of between four and six months of estimated forward demand held in approximately 150 locations in the U.S. Channel inventory fluctuates quarter to quarter and changes over time. Deferred product revenue does not include the other gross-to-net revenue adjustments (such as Medicaid rebates, managed care rebates, and chargebacks) which are included in accrued liabilities Accrued liabilities are liabilities which have occurred, but have not been paid or logged under accounts payable during an accounting period; in other words, obligations for goods and services provided to a company for which invoices have not yet been received. on the balance sheet. Going forward, revenue which has been deferred will be recognized as the product 'sells through' in future periods. Thus, future reported product sales will be estimates of end-user product demand and changes in channel inventory will impact deferred revenue on the balance sheet. As a result of the restatement process, six material weaknesses were identified in the company's internal control over its financial reporting. As a result, our internal control over financial reporting is not effective and we received an adverse opinion from BDO. Management has a commitment as a top priority to correct these material weaknesses and is taking action to strengthen its accounting and finance personnel, processes and controls in diligently dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d completing the remediation initiatives outlined in our Form 10-K.
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Year ended December 31,
------------------------------------
2004 2003 2002
(Restated) (Restated)
----------- ----------- ------------
Revenues:
Product sales $120,335 $55,324 $30,326
Collaborative research and
development and other revenues 43,177 25,794 41,443
----------- ----------- ------------
Total revenues 163,512 81,118 71,769
----------- ----------- ------------
Operating costs and expenses:
Cost of products sold 39,804 26,557 14,738
Research and development 65,204 66,678 59,060
Selling, general and
administrative 65,798 52,540 41,825
Co-promotion 30,077 9,360 -
----------- ----------- ------------
Total operating costs
and expenses 200,883 155,135 115,623
----------- ----------- ------------
Loss from operations (37,371) (74,017) (43,854)
Other expense, net (7,770) (20,449) (8,403)
----------- ----------- ------------
Loss before cumulative effect of a
change in accounting principle (45,141) (94,466) (52,257)
Cumulative effect of changing
method of accounting for variable
interest entity - (2,005) -
----------- ----------- ------------
Net loss $(45,141) $(96,471) $(52,257)
=========== =========== ============
Basic and diluted per share
amounts:
Loss before cumulative effect of a
change in accounting principle $(0.61) $(1.33) $(0.76)
Cumulative effect of changing
method of accounting for variable
interest entity - (0.03) -
----------- ----------- ------------
Net loss $(0.61) $(1.36) $(0.76)
=========== =========== ============
Weighted average number of
common shares 73,692,987 70,685,234 $69,118,976
=========== =========== ============
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
Year ended December 31,
-------------------------------
2004 2003 2002
(Restated) (Restated)
--------- ---------- ----------
Assets
Current assets:
Cash, cash equivalents and short-term
investments ($9,204, and $8,998,
restricted at December 31, 2003, and
2002, respectively) $112,492 $99,034 $64,248
Other current assets 60,332 43,742 32,387
--------- ---------- ----------
Total current assets 172,824 142,776 96,635
Restricted investments 2,378 1,656 10,646
Property and equipment, net 23,647 23,501 9,672
Acquired technology and product rights,
net 127,443 138,117 148,806
Other assets 6,174 7,996 21,950
--------- ---------- ----------
$332,446 $314,046 $287,709
========= ========== ==========
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities, excluding deferred
revenue $64,184 $53,987 $29,656
Current portion of deferred revenue,
net 152,528 105,719 48,609
--------- ---------- ----------
Total current liabilities 216,712 159,706 78,265
Long-term debt 167,089 167,408 155,250
Other long-term liabilities 11,637 9,891 10,674
Common stock subject to conditional
redemption 12,345 14,595 34,595
Stockholders' equity (deficit) (75,317) (37,554) 8,925
--------- ---------- ----------
$332,466 $314,046 $287,709
========= ========== ==========
Total Net Product Sales: Our total net product sales for 2004 were $120.3 million, compared to $55.3 million in 2003 and $30.3 million in 2002, increases of 118% and 82%, respectively. A comparison of sales by product is as follows (in thousands):
Year ended December 31,
----------------------------------------
2004 2003 2002
(Restated) (Restated)
------------ -------------- ------------
AVINZA $69,470 $16,482 $1,114
ONTAK 32,200 24,108 17,706
Targretin capsules 15,105 11,556 8,563
Targretin and Panretin
gels 3,560 3,178 2,943
------------ -------------- ------------
Total net product sales $120,335 $55,324 $30,326
============ ============== ============
AVINZA: Sales of AVINZA were $69.5 million in 2004 compared to $16.5 million in 2003. This increase is due to higher prescriptions as a result of the increased level of marketing and sales activity, which started in March 2003, and the product's success in achieving state Medicaid and commercial formulary status. According to IMS data, AVINZA ended 2004 with a market share of prescriptions of 3.9% compared to 1.4% at the end of 2003. Sales in 2004 also benefited from a 9.9% price increase effective January 1, 2004 and a 9.0% price increase effective July 1, 2004. AVINZA sales were negatively impacted during 2004 by a higher level of Medicaid rebates and also impacted by a higher level of rebates under certain managed care contracts entered into in late 2003 and early 2004 with pharmacy benefit managers (PBMs), group purchasing organizations A group purchasing organization is an entity that leverages the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members. Many GPOs are funded by administrative fees that are actually paid by the vendors. (GPOs) and health maintenance organizations (HMOs). Sales of AVINZA were $16.5 million in 2003 compared to $1.1 million in 2002. This increase is due to increasing prescriptions as a result of the increased level of marketing and sales activity and to 2003 being the first full year of AVINZA sales. Demand for AVINZA as measured by prescription levels (or patient consumption for channels with no prescription requirements) was 17 times greater for 2003 than for 2002, as reported by IMS Health. ONTAK: Sales of ONTAK were $32.2 million in 2004 compared to $24.1 million in 2003. Sales in 2004 were positively impacted by a 9% price increase effective January 1, 2004 and increasing use (impacted in part by expanded clinical data) in CTCL CTCL Cutaneous T Cell Lymphoma , CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid , and NHL NHL Non-Hodgkin's lymphoma, see there . Demand for ONTAK as measured by shipments to end users as reported by our wholesalers increased by 28% for 2004 compared to 2003. Sales of ONTAK in 2004 were negatively impacted, however, by a continued increase in chargebacks and rebates due to changes in patient mix and evolving reimbursement rates including disproportionate share hospitals (DSH). We expect that sales of ONTAK will be negatively impacted by changes to the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and reimbursement rates in 2005 but expect improved reimbursement rates, based on most recent ASP filings, moving into 2006. Sales of ONTAK were $24.1 million in 2003 compared to $17.7 million in 2002. This increase reflects price increases and increasing use (impacted in part by expanded clinical data) in CTCL, CLL, and NHL. Overall demand for ONTAK measured by unit shipments to end users increased 20% for 2003 compared to the prior year. Sales of ONTAK were negatively impacted, however, by increased chargebacks and rebates reflecting changes in our patient mix and reimbursement rates. Targretin Capsules Sales of Targretin capsules were $15.1 million in 2004 compared to $11.6 million in 2003. This increase reflects a 7% price increase effective January 1, 2004 and the full period impact of a 15% price increase effective April 1, 2003. Additionally, demand for Targretin capsules as measured by product out-movement increased by 5.4% for 2004 compared to 2003, as reported by IMS Health. In international markets, unit sales grew 37% over the prior year. Sales of Targretin capsules were $11.6 million in 2003 compared to $8.6 million in 2002. This increase reflects a 15% price increase effective April 1, 2003. Additionally, demand for Targretin capsules as measured by product out-movement increased by 1.0% for 2003 compared to 2002, as reported by IMS Health. In international markets, unit sales grew 173% over the prior year. Collaborative R&D/Other Revenues: Collaborative research and development and other revenues for 2004 were $43.2 million, compared to $25.8 million for 2003 and $41.4 million for 2002. Collaborative research and development and other revenues included $31.3 million from the sale of royalty rights in 2004, $11.8 million in 2003, and $17.6 million in 2002, respectively. Collaborative research and development and other revenues decreased in 2003 primarily due to lower levels of research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and from our two collaborative partners, lower milestones and lower revenues from sale of royalty rights compared to 2002. R&D: Research and development expenses were $65.2 million in 2004 compared to $66.7 million in 2003 and $59.1 million in 2002. Overall spending for research and development remained relatively constant in 2004 compared to 2003 with increases in research on internal programs offset by decreases in research performed under collaboration Working together on a project. See collaborative software. agreements and increases in existing product support offset by decreases in new product development. SG&A: Selling, general and administrative expenses were $65.8 million for 2004 compared to $52.5 million for 2003 and $41.8 million for 2002. Selling, general and administrative expenses increased in 2004 primarily due to costs associated with additional company's sales representatives hired to promote AVINZA and higher advertising and promotion expenses for AVINZA in connection with our co-promotion agreement activities. The increase in 2003 compared to the prior year is primarily due to costs associated with additional company sales representatives hired to promote AVINZA and higher advertising and promotion expenses for AVINZA which was launched in June 2002. Co-promotion: Co-promotion expense payable to Organon amounted to $30.1 million in 2004 compared to $9.4 million for 2003. (For a more complete description, see Co-promotion discussion earlier in this press release under "three and six months ended June 30, 2005 as compared to June 30, 2004.") The co-promotion agreement was not entered into until 2003 and therefore there is no co-promotion expense in 2002. Other Expense, Net: Other expense, net includes interest income, interest expense, and other miscellaneous expenses. Other expense, net were $7.8 million for 2004 compared to $20.4 million for 2003 and $8.4 million for 2002. Interest expense increased to $12.3 million for 2004 compared to $11.1 million for 2003 and $6.3 million for 2002. Interest expense in 2004 and 2003 primarily represents interest on the $155.3 million of 6% convertible subordinated Subordinated A claim ranked lower in priority than other claims. Common stock claims are always subordinated to debt. notes that we issued in November 2002. The 2002 interest expense represents interest on the $20.0 million in issue price of zero coupon A certificate evidencing the obligation to pay an installment of interest or a dividend that must be cut and presented to its issuer for payment when it is due. Coupons are usually attached to a document, such as a promissory note, bond, share of stock, or a bearer convertible senior notes that were converted into common stock in March 2002 and interest on our outstanding $50.0 million face value of convertible subordinated debentures subordinated debenture An unsecured bond with a claim to assets that is subordinate to all existing and future debt. Thus, in the event that the issuer encounters financial difficulties and must be liquidated, all other claims must be satisfied before that were redeemed re·deem tr.v. re·deemed, re·deem·ing, re·deems 1. To recover ownership of by paying a specified sum. 2. To pay off (a promissory note, for example). 3. in June 2002. In September 2004, we agreed to vote our shares of X-Ceptor in favor of upon the side of; favorable to; for the advantage of. See also: favor the acquisition of X-Ceptor by Exelixis Exelixis is a genomics-based drug discovery company located in South San Francisco, Ca. It works on the development of anti-cancer therapies. Exelixis has several compounds in various stages of FDA approval and is listed on NASDAQ (EXEL). External link
adv. 1. With that, this, or it. 2. In addition to that. 3. Archaic Immediately thereafter. Adv. 1. , Ligand received 618,165 shares of Exelixis common stock. We recorded a net gain on the transaction in the fourth quarter of 2004 of approximately $3.7 million, based on the fair market value of the consideration received. Other net expenses of $10.0 million in 2003 included the March 2003 write-off Write-Off A reduction in the value of an asset or earnings by the amount of an expense or loss. Companies are able to write off certain expenses that are required to run the business, or have been incurred in the operation of the business and detract from retained revenues. of a $5.0 million one-time one-time adj. 1. or one·time a. Occurring or undertaken only once: a one-time winner in 1995. b. payment made in July 2002 to X-Ceptor Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. , Inc. (or X-Ceptor) to extend Ligand's right to acquire the outstanding stock of X-Ceptor not already held by Ligand. In March 2003, we informed X-Ceptor that we would not exercise the purchase right and wrote-off the purchase right valued at $4.0 million that was recorded in 1999. Liquidity: Cash, cash equivalents, short-term investments, and restricted investments totaled $114.9 million at December 31, 2004 compared to $100.7 million at December 31, 2003. Restricted investments at December 31, 2004 consist of shares of Exelixis common stock and certificates of deposit held with a financial institution as collateral under equipment financing and third-party service provider arrangements. Restricted investments at December 31, 2003 also included U.S. government securities required to be held with a trustee A user or group of users that has been given access rights to files on a network server. See also TRUSTe. to pay the semi-annual interest payments due in 2004 on the 6% convertible subordinated notes issued in November 2002. Cash flow from operations Cash flow from operations A firm's net cash inflow resulting directly from its regular operations (disregarding extraordinary items such as the sale of fixed assets or transaction costs associated with issuing securities), calculated as the sum of net income plus noncash expenses turned positive in 2003 after significant use in 2002. Operating activities provided cash of $5.8 million in 2004, including the benefit from increased product shipments and $32.5 million of cash received from the sale of royalty rights to Royalty Pharma Pharma may be an abbreviation for:
Business Update A restatement, by its nature, looks backward. Comparing the most recent results to date in 2005 with prior periods, the company's total product sales continue to grow. Going forward into 2006, Ligand may potentially benefit from progress among its key assets, including: Ligand Specialty A contract under seal. A specialty is a written document that has been sealed and delivered and is given as security for the payment of a specifically indicated debt. Products: --Reaccelerating AVINZA sales growth through improved sales call productivity once issues related to the current co-promotion relationship are resolved as well as anticipated increased demand as final data is published from recent comparative Phase IV clinical trials Noun 1. phase IV clinical trial - sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier . --ONTAK sales growth resulting from improved reimbursement rates, a recent price increase, and further data from ongoing, expanded-use clinical trials. --Expected further development of Targretin capsules in NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there through a patient sub-group registration trial to be conducted with a partner based on analysis from the recently completed SPIRIT trials. --Incremental annual operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. reduction (ongoing) of $15 million from 2005 annual run rate to rightsize the company's cost structure with the goal of accelerating the elimination of operating losses consistent with revenue run rates. Expense reductions span SG&A and R&D and include both increased project focus (low-priority project terminations) and headcount head count or head·count n. 1. The act of counting people in a particular group. 2. The number of people counted in this way. Noun 1. controls and infrastructure reductions and elimination of one-time restatement expense. --Initiation of Phase I trials and rapid development of LGD LGD Loss Given Default LGD Livestock Guardian Dog LGD Low-Grade Dysplasia (abnormal cells, such as those found when doing a biopsy) LGD Laboratory of Genomic Diversity LGD Lou Gehrig's Disease 4665, a thrombopoietin thrombopoietin an a2-globulin, a hormone involved in the differentiation and maturation of platelets but thought to be responsible for regulating the supply of platelets. oral mimic currently on IND track for thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. . --Initiation of Phase I trials for LGD 5552, a selective glucocorticoid glucocorticoid /glu·co·cor·ti·coid/ (-kor´ti-koid) 1. any of the group of corticosteroids predominantly involved in carbohydrate metabolism, and also in fat and protein metabolism and many other activities (e.g. agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. currently on IND track for inflammation inflammation, reaction of the body to injury or to infectious, allergic, or chemical irritation. The symptoms are redness, swelling, heat, and pain resulting from dilation of the blood vessels in the affected part with loss of plasma and leucocytes (white blood and cancer. Corporate Partner Products: Corporate partner products are expected to continue progressing in development, based on information received from our corporate partners, including: --Resolution of the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any status of lasofoxifene Lasofoxifene (INN) is a selective estrogen receptor modulator (SERM) which is under development for the prevention and treatment of osteoporosis and for the treatment of vaginal atrophy. In September 2005, Pfizer Inc. received a non-approvable letter from the U.S. (Oporia) for osteoporosis osteoporosis (ŏs'tēō'pərō`sĭs), disorder in which the normal replenishment of old bone tissue is severely disrupted, resulting in weakened bones and increased risk of fracture; osteopenia prevention and the SNDA SNDA Supplemental New Drug Application SNDA Student National Dental Association SNDA Subordination, Non-Disturbance and Attornment SNDA Singapore Nutrition and Dietectics Association SNDA Southern Nevada Darts Association (Las Vegas, Nevada) status for vaginal atrophy vaginal atrophy Atrophic vaginitis, see there . --Submission of the bazedoxifene Bazedoxifene is a selective estrogen receptor modulator (SERM), developed by Wyeth Pharmaceuticals, undergoing clinical evaluation for the prevention and treatment of postmenopausal osteoporosis. NDA for osteoporosis. --Submission of an NDA for SB497115 for thrombocytopenia, pending successful completion of Phase IIB IIB Institute for Independent Business IIB Institute of International Business IIB Institute of International Bankers IIB International Investment Bank IIB Indian Institute of Banking & Finance IIB Included in Bankruptcy IIB Ice, Ice, Baby trials. --Initiation of Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials of naveglitizar (LY818) for type II diabetes Type II diabetes Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise. Mentioned in: Diabetic Ketoacidosis post completion of long-term Long-term Three or more years. In the context of accounting, more than 1 year. long-term 1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term. animal safety studies if successful. --Phase IA/B data publication and Phase II initiation initiation, the transition and attendant ceremonies, such as ordeals and rites, involved in passing from one state or status to another, often from childhood to adulthood. It was among the most important social institutions of early humans. for LGD 2941, a selective androgen androgen (ăn`drəjən): see testosterone. androgen Any of a group of hormones that mainly influence the development of the male reproductive system. agonist, for frailty frailty Vox populi A state of delicacy or weakness which, which encompasses age-related fragility, in particular osteoporosis. See FICSIT, Osteoporosis. . --Phase II data on LY674 in atherosclerosis atherosclerosis (ăth'ərōsklərō`sĭs): see arteriosclerosis. atherosclerosis or hardening of the arteries . We are developing several proprietary products for which we have worldwide rights for a variety of cancers and skin diseases, as summarized in the table below. This table is not intended to be a comprehensive list of our internal research and development programs. Many of the indications being pursued may present larger market opportunities for our currently marketed products.
Ligand Internal Product Pipeline
--------------------------------
Program Disease/Indication Development Phase
----------------------------------------------------------------------
AVINZA Chronic, moderate-to- Marketed in U.S.
severe pain Phase IV
ONTAK CTCL Marketed in U.S., Phase
IV
CLL Phase II
Peripheral T-cell Phase II
lymphoma
B-cell NHL 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 Planned Phase II/III
line
Advanced breast cancer Phase II
Renal cell cancer Phase II
Targretin gel CTCL Marketed in U.S.
Hand dermatitis Planned Phase II/III
(eczema)
Psoriasis Phase II
LGD4665
(Thrombopoietin Chemotherapy-induced IND Track
oral mimic) thrombocytopenias
(TCP), other TCPs
LGD5552
(Glucocorticoid Inflammation, cancer IND Track
agonists)
Selective androgen Male hypogonadism, Pre-clinical
receptor modulators, female & male
e.g., LGD3303 osteoporosis, male &
(agonist/antagonist) female sexual
dysfunction, frailty,
prostate cancer,
hirsutism, acne,
androgenetic alopecia
Corporate Partner Pipeline: Our corporate partners have made significant strides in developing collaborative product candidates, with several products in or nearing submission Submission Elliott, Anne reluctantly gives up her fiancé on her family’s advice. [Br. Lit.: Jane Austen Persuasion in Magill I, 734] for market approval. As of August 31, 2005, 13 of our collaborative product candidates had entered and were in human development - lasofoxifene, bazedoxifene, bazedoxifene CE (PREMARIN combo), pipendoxifene, NSP (1) (Network Service Provider) An organization that provides a high-speed Internet backbone to ISPs and other service providers. Sprint, MCI and UUNET are examples of NSPs. See Internet backbones. 989, NSP989 combo, LGD2941, GW516, LY818, LY929, LY674, SB497115, and SB559448. The table below summarizes our collaborative research and development programs, but is not intended to be a comprehensive summary of these programs.
Corporate Partner Products Pipeline
-----------------------------------
Program Disease/ Development Marketing Rights
Indication Phase
----------------------------------------------------------------------
SEX HORMONE MODULATORS
SERMs
-----
- Lasofoxifene Osteoporosis NDA and SNDA Pfizer
(1) prevention, filed
vaginal atrophy
- Lasofoxifene Breast cancer Phase III Pfizer
prevention,
Osteoporosis
treatment
- Bazedoxifene Osteoporosis Phase III Wyeth
- Bazedoxifene Osteoporosis Phase III Wyeth
CE prevention
Vasomoter
symptoms
- Pipendoxifene Breast cancer Phase II Wyeth
(formerly
ERA-923) (2)
PR modulators
-------------
- NSP-989 (PR Contraception Phase II Wyeth
agonist) (3)
- NSP-989 combo Contraception Phase I Wyeth
(PR agonist)
(3)
SARMs
-----
- LGD 2941 Osteoporosis, Phase I TAP
(androgen frailty, HT and
agonist) sexual
dysfunction
METABOLIC/CARDIOVASCULAR DISEASES
PPAR modulators
---------------
- GW516 Cardiovascular Phase II GlaxoSmithKline
disease,
dyslipidemia
- LY818 Type II diabetes Phase II Lilly
(naveglitazar)
(4)
- LY929 (5) Type II diabetes, Phase I Lilly
metabolic
diseases,
dyslipidemia
- LY674 Atherosclerosis/ Phase II Lilly
dyslipidemia
- LYWWW (6) Atherosclerosis IND track Lilly
- Selective Type II diabetes, IND track Lilly
PPAR metabolic
modulators diseases,
dyslipidemia
- LYYYY (6) Atherosclerosis Pre-clinical Lilly
INFLAMMATORY DISEASES, ONCOLOGY
- SB-497115 Thrombocytopenia Phase II GlaxoSmithKline
(TPO agonist)
- SB-559448 Thrombocytopenia Phase I GlaxoSmithKline
(TPO agonist)
(1) In September 2005, Pfizer announced receipt of a
non-approvable letter from the FDA for the prevention of
osteoporosis.
(2) Pipendoxifene development has been terminated for oncology; it
is currently on hold as a potential back-up to bazedoxifene.
(3) On internal hold; strategic alternatives for Phase III
development being explored.
(4) Lilly decision to advance to Phase III announced March 2004;
timing of initiation delayed by new FDA guidelines.
(5) Product placed on internal hold.
(6) Compound number not disclosed.
Strategic Alternatives Evaluation The board of directors and management of the company have reviewed the ongoing business, product assets, and the company's current strategic position and believe that while ongoing operational actions being taken should improve shareholder value translation, it is also appropriate to initiate INITIATE. A right which is incomplete. By the birth of a child, the husband becomes tenant by the curtesy initiate, but his estate is not consummate until the death of the wife. 2 Bouv. Inst. n. 1725. a process to explore strategic alternatives to enhance shareholder value. As a result, the board of directors has authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: and the company has engaged UBS UBS Union Bank of Switzerland UBS United Bible Societies UBS United Blood Services UBS United Buying Service UBS Used Bookstore UBS University Business Services UBS Universal Building Society (UK) UBS Ulaanbaatar Broadcasting System Securities LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control ("UBS") as investment banking advisors to assist the board of directors and management in that process. Now that the financial reporting normalization process is nearing completion, the company and UBS will implement a robust process of exploration of all strategic alternatives building upon work done over the past months. The Restatement and Other Related Matters Set forth below is a summary of the significant determinations regarding the restatement and additional matters addressed in the course of the restatement. Revenue Recognition: The restatement corrects the recognition of revenue for transactions involving each of the company's products that did not satisfy all of the conditions for revenue recognition contained in SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 48 - "Revenue Recognition when Right of Return Exists" ("SFAS 48") and Staff Accounting Bulletin ("SAB SAB Spontaneous abortion. See Abortion. No. 101") "Revenue Recognition" as amended a·mend v. a·mend·ed, a·mend·ing, a·mends v.tr. 1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive. 2. by SAB 104 (hereinafter here·in·af·ter adv. In a following part of this document, statement, or book. hereinafter Adverb Formal or law from this point on in this document, matter, or case Adv. 1. referred to as "SAB 104"). The company's products impacted by this restatement are the domestic product shipments of AVINZA, ONTAK, Targretin capsules, and Targretin gel. Specifically, although the company believed it had met each of the criteria for recognizing revenue upon shipment of each of its products, management subsequently 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: (1) a lack of sufficient visibility into the wholesaler and retail distribution channels; (2) an absence of historical experience with similar products; (3) increasing levels of inventory in the wholesale and retail distribution channels as a result of increasing demand of the company's new products among other factors; and (4) 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 must be restated using the sell-through method. The restatement of product revenue under the sell-through method requires the correction CORRECTION,punishment. Chastisement by one having authority of a person who has committed some offence, for the purpose of bringing him to legal subjection. 2. It is chiefly exercised in a parental manner, by parents, or those who are placed in loco parentis. of other accounts whose balances are 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(R) or the company's international product sales. For Panretin, our wholesalers only stock minimal amounts of product, if any. As such, wholesaler orders are considered to approximate ap·prox·i·mate v. To bring together, as cut edges of tissue. adj. 1. Relating to the contact surfaces, either proximal or distal, of two adjacent teeth; proximate. 2. Close together. end-customer demand for the product. For international sales, our products are sold to third-party distributors Third-Party Distributor The name given to institutions that sell or distribute mutual funds to investors for fund management companies without direct relation to the fund itself. , for which we have minimal returns. For these sales, the company believes 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 dosage /dos·age/ (do´saj) the determination and regulation of the size, frequency, and number of doses. dos·age n. 1. Administration of a therapeutic agent in prescribed amounts. 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 Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. 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 which was used in the restatement and will be used on a going-forward basis. Under the sell-through method used in the restatement and to be used 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 An itemized statement or written account of goods sent to a purchaser or consignee by a vendor that indicates the quantity and price of each piece of merchandise shipped. A consular invoice is one used in foreign trade. 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 Other Current Assets A balance sheet item that includes the value of non-cash assets due within one year. Notes: Examples are things like prepaid expenses and accounts receivable. ." 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 (algorithm) first-in first-out - (FIFO, or "queue") A data structure or hardware buffer from which items are taken out in the same order they were put in. Also known as a "shelf" from the analogy with pushing items onto one end of a shelf so that they fall off the other. (FIFO (First In First Out) A storage method that retrieves the item stored for the longest time. Contrast with LIFO. See traffic engineering methods. FIFO - first-in first-out ) 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 company's product revenues, but will be reflected on the balance sheet as a change to deferred product revenue. Sell-through for ONTAK, Targretin capsules, and Targretin gel is considered to be at the time the product moves from the wholesaler to the wholesaler's customer. Changes in wholesaler inventories for all the company's 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 company's 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 company's sales and revenue recognition under the sell-through method reflect the company's 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 val·i·date tr.v. val·i·dat·ed, val·i·dat·ing, val·i·dates 1. To declare or make legally valid. 2. To mark with an indication of official sanction. 3. against the company's 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 will be 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 Shrinkage The amount by which inventory on hand is shorter than the amount of inventory recorded. Notes: The missing inventory could be due to theft, damage, or book keeping errors. at wholesalers or retail pharmacies. As a result of the company's adoption of the sell-through method, it recorded reductions to net product sales in the amounts of $12.8 million, $8.1 million and $9.2 million for the quarters ended September 30, 2004, June 30, 2004 and March 31, 2004, respectively, and $25.5 million, $13.4 million, $12.8 million, and $7.5 million for the quarters ended December 31, 2003, September 30, 2003, June 30, 2003, and March 31, 2003, respectively. Additionally, for the years ended December 31, 2003 and 2002, the company recorded a reduction to net product sales in the amounts of $59.2 million and $24.2 million, respectively. These amounts do not include other adjustments also affected by the change to the sell-through method such as cost of products sold and royalties. 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 se·lec·tive estrogen receptor modulator n. Abbr. SERM A nonsteroidal compound, such as raloxifene or tamoxifen, designed to mimic the effect of estrogen on a specific tissue or body part by binding only to that part's estrogen receptors. (SERM SERM abbr. selective estrogen receptor modulator SERM Selective estrogen receptor modulator, see there ) products now in late stage development with two of the company's collaborative partners, Pfizer Pfizer Incorporated (NYSE: PFE) is a major research-based pharmaceutical company, which ranks number two in sales The company is based in New York City. It produces the number-one selling drug Lipitor (atorvastatin, used to lower blood cholesterol); the oral antifungal Inc. and American Home For the American mortgage lender, see . The American Home is a center of intercultural exchange located in Vladimir, Russia. The home is designed to model a typical American suburban home and its main focus is the ESL school that provides lessons for Russian students. 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. Cumulative payments totaling $63.3 million were received from Royalty Pharma from 2002 through 2004 for the sale of royalty rights from the net sales of the SERM products. The company determined that, while the current accounting classification is appropriate, 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 developmental milestones Developmental milestones are tasks most children learn, or physical developments, that commonly appear in certain age ranges. For example:
v. de·ferred, de·fer·ring, de·fers v.tr. 1. To put off; postpone. 2. To postpone the induction of (one eligible for the military draft). v.intr. a portion of such revenue as it relates to the value of the option rights sold to Royalty Pharma until Royalty Pharma exercises such options or upon the expiration EXPIRATION. Cessation; end. As, the expiration of, a lease, of a contract, or statute. 2. In general, the expiration of a contract puts an end to all the engagements of the parties, except to those which arise from the non- fulfillment of obligations created of the options. The value of Royalty Pharma options outstanding at the end of 2002 which was recognized in 2003 was approximately $0.1 million. The value of options outstanding at the end of 2003 which was recognized in 2004 was $0.2 million. As of December 31, 2004, all of the option revenue deferred during fiscal years 2002 and 2003 has been recognized. Accordingly, for the years ended December 31, 2003 and 2002, the company has restated revenue from the sale of royalty rights under the Royalty Pharma agreement, which reduced royalty revenue by approximately $0.7 million for each of the years ended December 31, 2003 and 2002. Additional Matters Addressed in the Restatement Subsequent to May 20, 2005, the company determined that it should also restate re·state tr.v. re·stat·ed, re·stat·ing, re·states To state again or in a new form. See Synonyms at repeat. re·state its consolidated financial statements as they relate to the following matters: Buy-Out buy·out also buy-out n. 1. The purchase of the entire holdings or interests of an owner or investor. 2. The purchase of a company or business: of Salk Salk , Jonas 1914-1995. American microbiologist who developed (1954) the first effective killed-virus vaccine against polio. Royalty Obligation: In March 2004, the company paid The Salk Institute $1.12 million in connection with the company's 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 which a NDA was expected to be filed in 2004. At the time of the company's exercise of its buyout Buyout The purchase of a company or a controlling interest of a corporation's shares. Notes: A leveraged buyout is accomplished with borrowed money or by issuing more stock. right, the payment was accounted for as a prepaid pre·pay tr.v. pre·paid, pre·pay·ing, pre·pays To pay or pay for beforehand. pre·pay ment n. royalty asset to be amortized on
a straight-line straight-lineadj. 1. Lying in a straight line. 2. Relating to a device whose linkage produces or copies motion in straight lines. 3. basis over the period for which the company had a contractual right to the lasofoxifene royalties. This payment was included in "Other assets other assets Assets of relatively small value. For financial reporting purposes, firms frequently combine small assets into a single category rather than listing each item separately. " on the company's consolidated balance sheet at September 30, 2004, June 30, 2004, and March 31, 2004. Pfizer filed the NDA for lasofoxifene with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. 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 quarter ended March 31, 2004 and the year ended December 31, 2004. X-Ceptor Therapeutics, Inc.: In June 1999, the company invested $6.0 million in X-Ceptor Therapeutics, Inc. ("X- Ceptor") through the acquisition of convertible preferred stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". . Additionally, in October 1999, the company issued warrants to X-Ceptor investors, founders and certain employees to purchase 950,000 shares of Ligand common stock with an exercise price of $10.00 per share and an expiration date Expiration Date The day on which an options or futures contract is no longer valid and, therefore, ceases to exist. Notes: The expiration date for all listed stock options in the U.S. of October 6, 2006. At the time of issuance, the warrants were recorded at their fair value of $4.20 per warrant or $4.0 million as deferred warrant expense within stockholders' deficit and were amortized to operating expense through June 2002. The company determined during the course of the restatement that the warrant issue should have been capitalized as an asset rather than treated as a deferred expense within equity since the warrant issue was deemed to be consideration for the right granted to the company by X-Ceptor to acquire all of the outstanding stock of X-Ceptor (the "Purchase Right"). Accordingly, the company recorded the Purchase Right as an other asset in the amount of $4.0 million. The effect of this change resulted in a decrease in expense for the year ended December 31, 2002 of $0.7 million. This asset was subsequently written off to "Other, net expense" in the quarter ended March 31, 2003, the period the company determined that the Purchase Right would not be exercised. Pfizer Settlement Agreement and Elan (Emulated LAN) A virtual LAN in the ATM world. See LANE and virtual LAN. Elan - ["Top-down Programming with Elan", C.H.A. Koster, Ellis Horwood 1987]. Shares: In April 1996, the company and Pfizer entered into a settlement agreement with respect to a lawsuit lawsuit: see procedure; tort. 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 company's 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 company's 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 balance sheet. Additionally, in 1998, Elan International (Elan) agreed to exclusively license to the company in the United States and Canada Canada (kăn`ədə), independent nation (2001 pop. 30,007,094), 3,851,787 sq mi (9,976,128 sq km), N North America. Canada occupies all of North America N of the United States (and E of Alaska) except for Greenland and the French islands of its proprietary product AVINZA. In connection with the November 2002 restructuring of the AVINZA license agreement with Elan, the company agreed to repurchase re·pur·chase tr.v. re·pur·chased, re·pur·chas·ing, re·pur·chas·es To buy (something) again. n. The act of buying something that one previously sold or owned. Noun 1. approximately 2.2 million shares of the company's common stock held by an affiliate Affiliate Relationship between two companies when one company owns substantial interest, but less than a majority of the voting stock of another company, or when two companies are both subsidiaries of a third company. See: Subsidiaries, parent company. of Elan (the "Elan Shares"). At the time of the November 2002 agreement, the shares were classified as equity on the company's balance sheet. The Elan Shares were repurchased and retired in February February: see month. 2003. In conjunction conjunction, in astronomy conjunction, in astronomy, alignment of two celestial bodies as seen from the earth. Conjunction of the moon and the planets is often determined by reference to the sun. with the restatement, the remaining common stock issued and outstanding to Pfizer following the settlement and the Elan Shares were reclassified as "common stock subject to conditional Subject to change; dependent upon or granted based on the occurrence of a future, uncertain event. A conditional payment is the payment of a debt or obligation contingent upon the performance of a certain specified act. redemption/repurchase" (between liabilities and equity) in accordance with Emerging Issue Task Force Topic D-98, "Classification and Measurement of Redeemable Redeemable Eligible for redemption under the terms of an indenture. Securities" (EITF EITF Emerging Issues Task Force EITF Edinburgh International Television Festival EITF Europe International Taekwon-Do Federation 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 The liberation of an estate in real property from a mortgage. Redemption is the process by which land that has been mortgaged or pledged is bought back or reclaimed. It is accomplished through a payment of the debt owed or a fulfillment of the other conditions. of securities that is not solely within the control of the issuer. Since Pfizer has the option to settle with company's shares milestone and royalty payments owed to the company and, as of December 31, 2002, the company was required to repurchase the Elan shares, the company determined that such factors indicated that the redemptions were not within the company's control, and accordingly, EITF D-98 was applicable to the treatment of the common stock issued to Pfizer and the Elan Shares. These adjustments totaling $34.6 million only had an effect on the balance sheet classification, not on the consolidated con·sol·i·date v. con·sol·i·dat·ed, con·sol·i·dat·ing, con·sol·i·dates v.tr. 1. To unite into one system or whole; combine: statements of operations. Seragen Litigation: In December 2001, a lawsuit was filed against the company by the Trustees of Boston University Boston University, at Boston, Mass.; coeducational; founded 1839, chartered 1869, first baccalaureate granted 1871. It is composed of 16 schools and colleges. and other former stakeholders of Seragen, alleging breach of contract, breach of the implied Inferred from circumstances; known indirectly. In its legal application, the term implied is used in contrast with express, where the intention regarding the subject matter is explicitly and directly indicated. covenants of good faith and fair dealing and unfair and deceptive de·cep·tive adj. Deceptive or tending to deceive. de·cep tive·ness n. trade practices based
on, among other things, allegations that the company wrongfully wrong·ful adj. 1. Wrong; unjust: wrongful criticism. 2. Unlawful: wrongful death. withheld approximately $2.1 million in consideration due the plaintiffs under the Seragen acquisition agreement. This amount had been previously accrued ac·crue v. ac·crued, ac·cru·ing, ac·crues v.intr. 1. To come to one as a gain, addition, or increment: interest accruing in my savings account. 2. for in the company's consolidated financial statements in 1998. In November 2003, the Court granted Boston Boston, town, England Boston, town (1991 pop. 26,495), E central England, on the Witham River. Boston's fame as a port dates from the 13th cent., when it was a Hanseatic port trading wool and wine. Having recovered from a decline in the 18th and 19th cent. University's motion for summary judgment motion for summary judgment n. a written request for a judgment in the moving party's favor before a lawsuit goes to trial and based on recorded (testimony outside court) affidavits (or declarations under penalty of perjury), depositions, admissions of fact, answers , 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 the first quarter of 2004, the Court award of interest was not accrued. Although the company has appealed the judgment in this case as well as the award of interest and the calculation of 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 company's estimate of the accrual accrual, n continually recurring short-term liabilities. Examples are accrued wages, taxes, and interest. 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. Impact of Restatement: For the quarters ended September 30, 2004, June 30, 2004, and March 31, 2004, the restatement increased the net loss by $11.7 million or $0.16 per share; $7.8 million or $0.11 per share; and $8.8 million or $0.12 per share, respectively. The restatement increased the net loss in 2003 by $59.0 million or $0.83 per share to $96.5 million or $1.36 per share. The restatement increased the net loss in 2002 by $19.7 million or $0.29 per share to $52.3 million or $0.76 per share. For periods prior to 2002, the restatement was effectuated through an aggregate adjustment as of January 1, 2002 of $15.1 million to the company's accumulated ac·cu·mu·late v. ac·cu·mu·lat·ed, ac·cu·mu·lat·ing, ac·cu·mu·lates v.tr. To gather or pile up; amass. See Synonyms at gather. v.intr. To mount up; increase. deficit. Additionally, for periods prior to 2002, restatement of the Pfizer settlement agreement was effectuated as of January 1, 2002 through a reduction of additional paid in capital and a corresponding increase to "common stock subject to conditional redemption/repurchase" (between liabilities and equity) of $14.6 million. The restatement regarding the Elan shares had no effect on periods prior to 2002 since it was effectuated as of November 2002 through a reduction of additional paid in capital and a corresponding increase to "common stock subject to conditional redemption/repurchase" of $20.0 million. Internal Control Over Financial Reporting: Based on an evaluation of disclosure controls and procedures, our CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and CFO See Chief Financial Officer. concluded that the company's disclosure controls and procedures were not effective as of December 31, 2004 due to the following material weaknesses, which have been discussed with the company's audit committee: revenue recognition; shipments of short-dated Short´-dat`ed a. 1. Having little time to run from the date. Adj. 1. short-dated - of a gilt-edged security; having less than 5 years to run before redemption Britain, Great Britain, U.K. product; record keeping and documentation; accounting personnel; accruals Accruals Accounts on a balance sheet that represent liabilities and non-cash-based assets used in accrual-based accounting. These accounts include, among many others, accounts payable, accounts receivable, goodwill, future tax liability and future interest expense. and cut-offs and financial reporting and closing. These material weaknesses have not been completely remediated as of the date of this press release. A complete discussion of our completed and continuing remediation efforts is contained in our Annual Report on Form 10-K for the year ended December 31, 2004 filed today with the SEC. Restatement Adjustments The company adopted the sell-through revenue recognition method as its new revenue recognition policy. 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 company's 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 wholesaler's customer. Likewise, changes in wholesaler inventories of these products do not affect the company's product revenue, but will be reflected on the balance sheet under deferred revenue, net. As such, changes in wholesaler inventories for all the company's 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 company's products is 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: --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." 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 Revaluation A calculated adjustment to a country's official exchange rate relative to a chosen baseline. The baseline can be anything from wage rates to the price of gold to a foreign currency. In a fixed exchange rate regime, only a decision by a country's government (i.e. is likewise reflected as a charge to the company's statement of operations See Income statement. in the period the company announces such price increase. --Royalties - 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. Restatement Adjustments The majority of the restatement adjustments outlined for 2003 and 2002 reconciliations in the financial tables which follow are a result of the adoption of the sell-through revenue recognition method. The largest reduction in product sales of $59.3 million occurred in 2003, driven primarily by AVINZA, is reflective Refers to light hitting an opaque surface such as a printed page or mirror and bouncing back. See reflective media and reflective LCD. of the expansion of retail pharmacy stocking and wholesale inventories, previously disclosed dis·close tr.v. dis·closed, dis·clos·ing, dis·clos·es 1. To expose to view, as by removing a cover; uncover. 2. To make known (something heretofore kept secret). , in support of the ramp up Ramp Up To increase a company's operations in anticipation of increased demand. Notes: A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product. See also: Demand, Economies of Scale of product demand in the first year of co-promotion. Additionally, 2002 product sales were reduced $24.2 million, primarily driven by AVINZA, in the year of product launch where initial distribution was established and by ONTAK as a result of expansion of wholesale distribution. Corresponding adjustments are reflected as a liability on the balance sheet showing revenue deferred. In addition, the company also restated its financials as a result of review of several historic, complex transactions and made other adjustments and reclassifications which are included in tables and footnotes. Following are tables which reconcile previously reported financial results with restated financial results, including adjustments made in connection with the restatement.
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands, except share and per share data)
Year ended December 31, 2003
-----------------------------------------
As Adjustments As Restated
Previously
Reported
----------- ----------------- -----------
Product sales $114,632 $(59,308)(a)(b) $55,324
Collaborative research and
development and other
revenues 26,508 (714) (c) 25,794
----------- ----------------- -----------
Total revenues 141,140 (60,022) 81,118
Operating costs and expenses:
Cost of products sold 31,618 (5,061) (d) 26,557
Research and development 67,679 (1,001)(b)(e)(f) 66,678
Selling, general and
administrative 51,661 879 (b)(f)(g) 52,540
Co-promotion 9,360 9,360
----------- ----------------- -----------
Total operating costs and
expenses 160,318 (5,183) 155,135
----------- ----------------- -----------
Loss from operations (19,178) (54,839) (74,017)
Other expense, net (16,279) (4,114)(b)(h)(i) (20,393)
----------- ----------------- -----------
Loss before cumulative effect
of a change in accounting
principle (35,457) (58,953) (94,410)
Income tax expense - 56 (i) (56)
----------- ----------------- -----------
Loss before cumulative effect
of a change in accounting
principle (35,457) (59,009) (94,466)
Cumulative effect of changing
method of accounting for
variable interest entity (2,005) (2,005)
----------- ----------------- -----------
Net loss $(37,462) $(59,009) $(96,471)
=========== ================= ===========
Basic and diluted per share
amounts:
Loss before cumulative effect
of a change in accounting
principle $(0.50) $(1.33)
Cumulative effect of changing
method of accounting for
variable interest entity (0.03) (0.03)
----------- -----------
Net loss $(0.53) $(1.36)
=========== ===========
Weighted average number of
common shares 70,685,234 70,685,234
=========== ===========
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 - $(59,187).
(b) To reflect other adjustments and reclassifications.
(c) To reflect the deferral of a portion of the sale of the
royalty rights to Royalty Pharma.
(d) To reflect the effect of the sell-through revenue recognition
method on cost of products sold and royalties - product cost -
$(151); royalties - $(4,910).
(e) To correct clinical trial expense - $(918).
(f) To reclassify $55 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.
(g) To reflect interest expense for the Seragen acquisition
liability - $739.
(h) To reflect the write-off of the X-Ceptor Purchase Right in
March 2003 - $3,990.
(i) To reclassify income taxes related to international operations
- $56.
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEET
(in thousands)
December 31, 2003
-------------------------------
As Cumulative Effect of
Previously Prior Year
Reported Adjustments
-------------------------------
Assets
Current assets:
Cash, cash equivalents and short-term
investments $99,034
Other current assets 31,123 $8,062 (a)(b)
---------- -------------------
Total current assets 130,157 8,062
Restricted investments 1,656
Property and equipment, net 23,501
Acquired technology and product rights,
net 137,857 260 (a)(d)
Other assets 8,084 3,958 (a)(e)
---------- -------------------
$301,255 $12,280
========== ===================
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities, excluding deferred
revenue $51,485 $(1,016)(a)(f)
(g)(j)
Current portion of deferred revenue 2,564 43,926 (i)
Long-term debt 167,408
Other long-term liabilities 9,070 (135)(j)(k)
(l)
Common stock subject to conditional
redemption/repurchase 34,595 (m)
Stockholders' equity (deficit) 70,728 (65,090)(a)(m)
---------- -------------------
$301,255 $12,280
========== ===================
December 31, 2003
----------------------------
Current Year As
Adjustments Restated
----------------------------
Assets
Current assets:
Cash, cash equivalents and short-term
investments $99,034
Other current assets $4,557 (a)(b)(c) 43,742
----------------------------
Total current assets 4,557 142,776
Restricted investments 1,656
Property and equipment, net 23,501
Acquired technology and product rights,
net 138,117
Other assets (4,046) (a)(c) 7,996
------------------ ---------
$511 $314,046
================== =========
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities, excluding deferred
revenue $3,518 (a)(f) $53,987
(h)(i)
Current portion of deferred revenue 59,229 (i) 105,719
Long-term debt 167,408
Other long-term liabilities 956 (j)(k)(l) 9,891
Common stock subject to conditional
redemption/repurchase (20,000) (n) 14,595
Stockholders' equity (deficit) (43,192) (n) (37,554)
------------------ ---------
$511 $314,046
================== =========
The adjustments relate to the following (in thousands):
(a) To reflect other adjustments and reclassifications.
(b) Cumulative effect of prior year adjustments includes $7,603
related to the change to the sell-through revenue recognition
method (deferred royalties - $4,215; deferred cost of products
sold - $3,388). Current year adjustments include $5,668
related to the change to the sell-through revenue recognition
method (deferred royalties - $5,465; deferred cost of products
sold - $203); correct prepaid clinical trial expense - $(254);
reclassify Organon cost-sharing receivable balance to
co-promotion liability - $(461).
(c) To correct bad debt expense - $(205).
(d) To correct accumulated amortization related to ONTAK acquired
technology - $357.
(e) To record the capitalization of the X-Ceptor Purchase Right in
October 1999 - $3,990; to write-off the X-Ceptor Purchase
Right in March 2003, which was previously recognized over the
period from 1999 to June 2002 - $(3,990).
(f) To correct clinical trial expense accrual. Cumulative effect
of prior year adjustments - $918; current year adjustments -
$(918).
(g) Includes $(1,089) related to the change to the sell-through
revenue recognition method (product cost - $(1,491); royalties
- $402); to correct accruals for bonus expense - $694; and
property tax expense - $(316); reclassification of Seragen
acquisition liability from other long-term liabilities -
$2,700; reclassification of the Elan shares from accrued
liabilities to additional paid-in capital - $(4,133).
(h) Includes $446 adjustment related to the change to the
sell-through revenue recognition method (product cost -
$(108); royalties $554); to correct bonus accrual - $(424); to
reclassify Organon cost-sharing receivable balance to
co-promotion liability - $(461); to reflect accrued interest
for the Seragen acquisition liability - $739; reclassification
of the Elan shares from accrued liabilities to additional
paid-in capital - $4,133.
(i) To reflect the change in the revenue recognition method from
the sell-in method to the sell-through method.
(j) To reclassify equipment lease obligation from long-term to
current obligation - $253.
(k) To reflect the deferral of a portion of the sale of the
royalty rights to Royalty Pharma - $592.
(l) The cumulative effect of prior year 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 - $2,237; to reclassify the Seragen
acquisition litigation to accrued liabilities - $(2,700).
Current year adjustment reflects the adjustment to rent
expense for contractual annual rent increase recognized over
the lease term on a straight line basis - $111.
(m) In accordance with EITF D-98, to reclassify from equity the
Company's issuance of common stock to Pfizer - $(34,595)
-common stock - $(1); additional paid in capital $(14,594) and
Elan shares - common stock $(2); additional paid in capital
$(19,998); reclassification of the Elan shares from accrued
liabilities to additional paid-in capital - $4,133.
(n) To reflect the repurchase and retirement of the Elan shares in
February 2003 - $20,000 - common stock - $2; additional
paid-in capital - $19,998; reclassification of the Elan shares
from accrued liabilities to additional paid-in capital -
$(4,133).
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands, except share and per share data)
Year ended December 31, 2002
---------------------------------------
As Adjustments As Restated
Previously
Reported
----------- --------------- -----------
Product sales $54,522 $ (24,196)(a)(b) $30,326
Collaborative research and
development and other revenues 42,118 (675)(c) 41,443
----------- --------------- -----------
Total revenues 96,640 (24,871) 71,769
Operating costs and expenses:
Cost of products sold 20,306 (5,568)(b)(d) 14,738
Research and development 58,807 253 (b)(e) 59,060
Selling, general and
administrative 41,678 147 (b) 41,825
----------- --------------- -----------
Total operating costs and
expenses 120,791 (5,168) 115,623
----------- --------------- -----------
Loss from operations (24,151) (19,703) (43,854)
Other expense, net (8,445) 86 (b)(f) (8,359)
----------- --------------- -----------
Loss before income taxes (32,596) (19,617) (52,213)
Income taxes (44)(f) (44)
----------- --------------- -----------
Net loss $(32,596) $(19,661) $(52,257)
=========== =============== ===========
Basic and diluted per share
amounts:
Net loss $(0.47) $(0.76)
=========== ===========
Weighted average number of
common shares 69,118,976 69,118,976
=========== ===========
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 - $(24,160).
(b) To reflect other adjustments and reclassifications.
(c) To reflect the deferral of a portion of the sale of the
royalty rights to Royalty Pharma.
(d) To reflect the effect of the sell-through revenue recognition
method on cost of products sold and royalties - product cost -
$(2,549); royalties - $(3,116).
(e) To correct clinical trial expense - $1,107; to reverse
X-Ceptor warrant amortization - $(692); to correct patent
expense accrual - $(345).
(f) To reclassify income taxes related to international operations
- $44.
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEET
(Unaudited)
(in thousands)
December 31, 2002
----------------------------
As Cumulative Effect
Previously of Prior Year
Reported Adjustments
----------------------------
Assets
Current assets:
Cash, cash equivalents and short-
term investments $64,248
Other current assets 24,325 $2,248 (a)(b)(c)
---------- ----------------
Total current assets 88,573 2,248
Restricted investments 10,646
Property and equipment, net 9,672 248 (d)
Acquired technology and product rights,
net 148,546 357 (e)
Other assets 17,992 3,868 (a)(f)
---------- ----------------
$275,429 $6,721
========== ================
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities, excluding deferred
revenue $30,672 $3,298 (a)(h)
Current portion of deferred revenue 4,683 18,423 (i)
Long-term debt 155,250
Other long-term liabilities 10,809 (621) (l)
Common stock subject to
redemption/repurchase 14,595 (m)
Stockholders' equity (deficit) 74,015 (28,974)(m)(o)(p)
---------- ----------------
$275,429 $6,721
========== ================
December 31, 2002
------------------------------
Current Year As
Adjustments Restated
------------------------------
Assets
Current assets:
Cash, cash equivalents and short-
term investments $64,248
Other current assets $5,814 (a)(b)(c) 32,387
------------------------------
Total current assets 5,814 96,635
Restricted investments 10,646
Property and equipment, net (248)(d) 9,672
Acquired technology and product rights,
net (97)(a) 148,806
Other assets 90 (a) 21,950
-------------------- ---------
$5,559 $287,709
==================== =========
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities, excluding deferred
revenue $(4,314)(a)(g) $29,656
(h)(j)
Current portion of deferred revenue 25,503 (i) 48,609
Long-term debt 155,250
Other long-term liabilities 486 (j)(k)(l) 10,674
Common stock subject to
redemption/repurchase 20,000 (n) 34,595
Stockholders' equity (deficit) (36,116)(a)(n)(o) 8,925
-------------------- ---------
$5,559 $287,709
==================== =========
The adjustments relate to the following (in thousands):
(a) To reflect other adjustments and reclassifications.
(b) To reverse replacement reserve due to the change to the
sell-through revenue recognition method.
(c) Cumulative effect of prior year adjustments includes $1,576
related to the change to the sell-through revenue recognition
method (deferred royalties - $1,055; deferred cost of products
sold - $521). Current year adjustments include $6,027 related
to the change to the sell-through revenue recognition method
(deferred royalties - $3,160; deferred cost of products sold -
$2,867).
(d) To accrue for fixed asset additions at December 31, 2001 -
$248.
(e) To correct accumulated amortization expense related to ONTAK
acquired technology.
(f) To record the capitalization of the X-Ceptor Purchase Right in
October 1999 - $3,990.
(g) To correct clinical trial expense accrual - $1,168 and fixed
asset additions - $(248).
(h) Cumulative effect of prior year adjustments includes $90
related to the change to the sell-through revenue recognition
method (product cost - $(268); royalties - $358); to correct
accruals for vendor expenses - $321, bonus expense - $236,
property tax expense - $(364); reclassification of Seragen
acquisition liability from other long-term liabilities -
$2,700. Current year adjustments include $(1,179) related to
the change to the sell-through revenue recognition method
(product cost - $(1,223); royalties - $44); correct accruals
for vendor expenses- $(321), bonus expense - $458, legal,
trademark and patent expense - $(263); reclassification of the
Elan shares from accrued liabilities to additional paid-in
capital - $(4,133).
(i) To reflect the change in the revenue recognition method from
the sell-in method to the sell-through method.
(j) To reclassify equipment lease obligation from long term to
current obligation - $(253).
(k) To reflect the deferral of a portion of the sale of the
royalty rights to Royalty Pharma - $581.
(l) The cumulative effect of prior year 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 - $2,079, to reclassify the Seragen
acquisition liability to accrued liabilities $(2,700). Current
year adjustment reflects the adjustment to rent expense for
contractual annual rent increase recognized over the lease
term on a straight line basis - $158.
(m) To reclassify from equity the Company's issuance of common
stock to Pfizer in accordance with EITF D-98 - $(14,595) -
common stock - $(1); additional paid in capital - $(14,594).
(n) To reclassify from equity the Elan shares in accordance with
EITF D-98 - $(20,000) - common stock - $(2); additional
paid-in capital - $(19,998); reclassification of the Elan
shares from accrued liabilities to additional paid-in capital
- $4,133.
(o) To write off deferred warrant amortization in connection with
the capitalization of the X-Ceptor Purchase Right.
(p) To reflect the cumulative effect, as of January 1, 2002, of
the restatement for years prior to 2000 - $(2,033) - product
sales - $(1,015), rent expense - $(1,614), royalties - $59,
reversal of X-Ceptor warrant amortization - $530, other - $7;
2000 - $(2,728) - product sales - $(4,092), rent expense -
$(255), royalties - $(235); reversal of X-Ceptor warrant
amortization - $1,384, amortization of acquired technology -
$357, other - $113; 2001 - $(10,310) - product sales -
$(13,585), rent expense - $(209), royalties - $1,368, reversal
of X-Ceptor warrant amortization - $1,384, other - $732.
Background of the Restatement On March 17, 2005, the company announced that in connection with the preparation of its consolidated financial statements for 2004 and the audit of those consolidated financial statements, the audit committee of the board of directors would conduct a review, with the assistance of management, of the company's revenue recognition policies and accounting for product sales, including its estimates of product returns under SFAS 48 and SAB 104. The review included the company's revenue recognition policies and practices for current and past periods as well as the company's internal control over financial reporting as it related to those items. The company also reviewed the accounting and classification of its sales of royalty rights in its consolidated statements of operations. The audit committee retained Dorsey Dor·sey , Tommy 1905-1956. American band leader. He and his brother Jimmy (1904-1957) were known for their swing bands that were particularly popular in the 1930s and 1940s. & Whitney LLP as independent counsel. The audit committee and independent counsel subsequently retained PricewaterhouseCoopers as their independent accounting consultants to assist in the review. In addition, the company, through its counsel, Latham Latham may refer to: People with the surname Latham:
People:
On May 20, 2005, the company announced that the audit committee had completed its accounting review and that the company would restate its consolidated financial statements as of December 31, 2003 and for the years ended December 31, 2003 and 2002, and for the first three quarters of 2004 and for the quarters of 2003. The audit committee and management independently reviewed the company's revenue recognition practices and policies for product sales for 2003 and 2002 and each of the three quarters in the period ended September 30, 2004. These reviews focused on whether the company had properly recognized revenue on product shipments to distributors under SFAS 48 and SAB 104. Based on these reviews, the company determined that it had not met all of the criteria under SFAS 48 and SAB 104 to recognize revenue upon shipment. As a result of this error, the company determined to restate its financial results and to report financial results under the sell-through revenue recognition method for the domestic product shipments of AVINZA, ONTAK, Targretin capsules, and Targretin gel. The company also announced that it was continuing its work to review the accounting and classification of its sales of royalty rights in its consolidated statements of operations and that the audit committee review found no evidence of improper
Subsequent to the company's announcement that it would restate its consolidated financial statements, the company's previous auditors AUDITORS, practice. Persons lawfully appointed to examine and digest accounts referred to them, take down the evidence in writing, which may be lawfully offered in relation to such accounts, and prepare materials on which a decree or judgment may be made; and to report the whole, together declined to be re-engaged to audit the restatement. As a result, the audit committee engaged BDO to re-audit the consolidated financial statements for the fiscal years ended December 31, 2003 and 2002, including the opening balance sheet as of January 1, 2002 which required the audit of certain transactions occurring in prior periods that impacted the opening balance sheet. During the course of the re-audits other errors were identified that affect the restated consolidated financial statements. In connection with the restatement, the SEC instituted a formal investigation concerning the company's 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 prompt adj. prompt·er, prompt·est 1. Being on time; punctual. 2. Carried out or performed without delay: a prompt reply. tr.v. as possible. Web Cast Conference Call Ligand will host a live web cast, open to all interested parties, of a conference call during which Ligand management will discuss this news release and review a corporate presentation. The conference call is scheduled for 8:00 a.m. eastern time on November 18, 2005. The web cast will be available at http://www.ligand.com (investor relations Investor relations The process by which the corporation communicates with its investors. page) and at http://www.streetevents.com and will be archived for 30 days. The slides used in the corporate presentation are available on the Ligand web site investor relations page and can be downloaded in advance of the conference call and web cast. The company intends to provide a more detailed business and R&D update at analyst/investor meetings to be held in various locations in November and December. About Ligand Ligand discovers, develops and markets new drugs that address critical unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs of patients in the areas of cancer, pain, skin diseases, men's and women's hormone-related diseases, osteoporosis, metabolic disorders Noun 1. metabolic disorder - a disorder or defect of metabolism disorder, upset - a physical condition in which there is a disturbance of normal functioning; "the doctor prescribed some medicine for the disorder"; "everyone gets stomach upsets from time to time" , and cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. and inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; . Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription Gene transcription The process by which genetic information is copied from DNA to RNA, resulting in a specific protein formation. Mentioned in: Gene Therapy technology, primarily related to intracellular receptors Intracellular receptors are receptors located inside the cell rather than on its cell membrane. Examples are the class of nuclear receptors located in the cell nucleus and the IP3 receptor located on the endoplasmic reticulum. . For more information, go to http://www.ligand.com. Caution regarding Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect Ligand's judgment and involve risks and uncertainties as of the date of this release. These statements include those related to 2005 financial data, estimates and discussion including management's expectations and trend analyses, other estimates and models, completion and filing of Forms 10-Q for the first three quarters of 2005, reapplication Re`ap`pli`ca´tion n. 1. The act of reapplying, or the state of being reapplied. and relisting on NASDAQ, dialogues and meetings with stockholders, the annual stockholders meeting, discussions with Organon, business update, product sales, growth and other initiatives, expense reductions, Ligand and corporate partner product development, strategic update and initiatives, material weaknesses, internal controls and remediation. Actual events or results may differ from Ligand's expectations and judgments. For example, there can be no assurance that when the company's subsequent processes such as compliance with NASDAQ Listing Qualifications Panel requirements will be completed, that the company will achieve relisting by the NASDAQ Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. and if so, when relisting will occur, that the annual meeting date will be held as expected, that the company's 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 execute To run a program, which causes the computer to carry out its instructions. See executable code, instruction and EXE file. execute - execution any of the mentioned business or strategic initiatives, including discussions with Organon, that the company will successfully or timely remediate re·me·di·a·tion n. The act or process of correcting a fault or deficiency: remediation of a learning disability. re·me any identified material weakness or significant deficiencies, that product sales will continue to grow or that pipeline products will be successfully developed or marketed, that the sell-through revenue recognition models will not require adjustment and not result in a subsequent restatement. In addition, the company's financial results and stock price may suffer as a result of the previously announced restatement and delisting Delisting When the stock of a company is removed from a stock exchange. Notes: Reasons for delisting include violating regulations and/or failure to meet financial specifications set out by the stock exchange. action by NASDAQ and its relationships with its vendors, stockholders or other creditors may suffer. The 2005 financial data and discussions presented in this press release are preliminary, unaudited and unreviewed and reflect the company's current estimates. They should be viewed as reflecting the company's expectations and with due regard to items still to be completed discussed elsewhere in this press release. Since the review of 2005 quarterly financial data by management is ongoing and BDO's review of those periods has not been completed, the 2005 financial information provided in this press release is subject to change and the changes, individually or in the aggregate, may be material to the company's financial position, results of operation or liquidity. Moreover, current and future financial results depend on estimates and the proper operation of highly-complex models, all of which are subject to change and errors. Such changes and/or and/or conj. Used to indicate that either or both of the items connected by it are involved. Usage Note: And/or is widely used in legal and business writing. errors may be material either individually or in the aggregate and could adversely affect our financial results, timeliness of SEC filings, NASDAQ listing and stock price. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available via Ligand's web site at www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. AVINZA, Targretin, ONTAK and Panretin are registered trademarks of Ligand Pharmaceuticals Incorporated. Each other trademark, trade name or service mark appearing in this news release belongs to its holder. |
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