Ligand Reports 2000 Results: Comparable Revenues Up 26%, Per Share Losses Down 33% and Product Sales Doubled From Prior Year.Business Editors & Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--March 19, 2001 Fourth Quarter 2000 Product Sales Up 206% and Net Loss Per Share Down 54% From 1999 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 (Nasdaq: LGND LGND Luminance Ground ) today reported that revenues excluding contract manufacturing services increased to $48.1 million for the year ended December 31, 2000, or 26% over comparable revenues in 1999, and losses before the cumulative effect of changing our method of revenue recognition declined 21% (33% per share) to $59.3 million ($1.06 per share) in 2000 versus $74.7 million ($1.58 per share) in 1999. Including the $13.1 million cumulative effect of such change, net losses for the year ended December 31, 2000, were $72.4 million ($1.30 per share). Revenues for the fourth quarter ended December 31, 2000, increased 11% to $13.8 million compared to $12.4 million for the fourth quarter ended December 31, 1999, and net losses declined 44% (54% per share) to $12.7 million ($0.22 per share) versus $22.9 million ($0.48 per share) in the year-earlier period. "In 2000, we achieved a healthy growth in revenues over 1999, including a doubling of product sales, and substantially reduced our operating loss 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. and net loss for the year (before the cumulative effect of a change in accounting principle), with the fourth quarter accelerating that trend," 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, Ligand Senior Vice President and Chief Financial Officer. "Ligand's 2000 financial results reflect a year in which we aligned our expense and capital structure to support the commercialization of our 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. and dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. products and lowered our break-even point break-even point - In the process of implementing a new computer language, the point at which the language is sufficiently effective that one can implement the language in itself. to better position ourselves for operating break-even on a quarterly basis in 2001. "Sales for our four marketed products grew from $11.3 million in 1999 to $22.9 million in 2000 and are expected to double again in 2001. Total other operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the 2000 year declined by $6.3 million, or 7%, with increases in commercialization expenses more than offset by R&D and G&A decreases. Research and development expenses declined for the second year in a row, by $8.2 million, or 14%, in 2000 compared to 1999 due to reduced clinical and 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 expenses coupled with overall continuing tight expense controls. "Our cash and capital structure improved in late 2000 and early 2001 through the issuance of $10.0 million (issue price) of the zero coupon convertible notes to 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]. , and 2,000,000 shares of common stock to institutional investors Institutional Investor A non-bank person or organization that trades securities in large enough share quantities or dollar amounts that they qualify for preferential treatment and lower commissions. , providing us with pro-forma cash and restricted cash as of December 31, 2000, of $57.5 million. We believe our cash resources will be sufficient to fund our operating needs through to break-even on a quarterly basis." Highlights of accomplishments in 2000 and early 2001: -- Doubled U.S. product sales: Launched Targretin(R) capsules in U.S. and secured FDA approval of and launched Targretin(R) gel -- Gained First European Product Approvals: Gained approval of Panretin(R) gel in Europe and received CPMP recommendation to approve Targretin capsules in Europe -- Added Elan Pharma International to our group of exclusive distributors, to market and distribute Ligand's five near-term oncology products in key countries in Eastern and Western Europe -- Reported positive Phase II clinical trial results showing Targretin capsules extended survival in patients with non-small cell lung cancer (NSCLC) -- Morphelan(TM) NDA filed with FDA by Elan for moderate to severe chronic pain. Ligand has U.S. marketing rights to Morphelan(TM) for the treatment of chronic pain in cancer and HIV patients. -- Advanced androgen agonist LGD2226 to human development track for male hypogonadism, female sexual dysfunction and osteoporosis -- Pfizer moved lasofoxifene into Phase III trials for osteoporosis -- AHP made a positive evaluation of TSE424 data in osteoporosis in preparation for initiation of Phase III trials in first half 2001; advanced WAY248 to IND track -- Lilly advanced three clinical candidates for diabetes and cardiovascular disease -- Bristol-Myers Squibb entered into collaboration with Ligand to discover and develop drugs to treat congestive heart failure, hypertension and other cardiovascular diseases -- Organon launched collaboration with Ligand to discover and develop drugs to address hormone replacement therapy, contraception and reproductive disorders 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. David E. Robinson, Ligand Chairman, President and Chief Executive Officer, "Our two product pipelines continued to expand and mature in 2000 at an exciting pace. In our Ligand Specialty Pharmaceutical Products pipeline, we now have four products approved and marketed, a fifth product pending approval, advancement of our flagship product A primary product of a company, which is typically why the company was founded and/or what made it well known. For example, MS-DOS, Windows and the Microsoft Office suite have been flagship products of Microsoft. CorelDRAW is a flagship product of Corel Corporation. , Targretin capsules, toward 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 in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. , and studies underway of our marketed products in other larger-market indications such as B-cell non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma , psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the and eczema eczema (ĕk`səmə), acute or chronic skin disease characterized by redness, itching, serum-filled blisters, crusting, and scaling. . The maturation maturation /mat·u·ra·tion/ (mach-u-ra´shun) 1. the process of becoming mature. 2. attainment of emotional and intellectual maturity. 3. of our existing commercial operations with the addition of a specialty dermatology sales force, providing increased focus and reach, and the launch of Morphelan(TM) (pending approval) in the U.S. and our EC-approved products in Europe through our exclusive distributors are all expected to contribute to further accelerate revenues during 2001. "In our Ligand Corporate Partner Products pipeline, the nine compounds already on human development track are moving through the development pipeline at an encouraging pace, with the first entering Phase III in 2000 and up to three additional compounds expected to move into Phase III in 2001 and 2002. In addition, we expect our research collaborations to add several new compounds for large-market indications to this pipeline during 2001. As these compounds progress through development, milestone and royalty revenues are expected to accelerate to become a significant component contributing to Ligand's operating results in 2001 and 2002." Comparison of 2000 versus 1999 Total revenues for 2000 were $48.1 million, an increase of $7.2 million, or 18%, as compared to 1999 revenues of $40.9 million. Product sales doubled to $22.9 million in 2000, from $11.3 million in 1999, as a result of $6.7 million in first-year 2000 sales of Targretin(R) capsules, a 61% increase in sales of ONTAK(R), from $8.2 million in 1999 to $13.2 million in 2000, and $1.1 million in first-year 2000 sales of Targretin gel. ONTAK and Panretin gel were approved for marketing in the U.S. in February 1999, and Targretin capsules and Targretin gel were approved in December 1999 and June 2000, respectively. ONTAK sales, which slowed somewhat in the second and third quarters of 2000 as a result of the launch of Targretin capsules, increased in the fourth quarter ended December 31, 2000, to $3.5 million from $2.9 million in the third quarter 2000. The fourth quarter growth in ONTAK sales resulted primarily from increased penetration of the private oncology practices. Targretin capsules achieved rapid first-year market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" and is positioned for further solid growth in 2001. Targretin gel launch was initiated in September 2000 and is expected to accelerate in 2001 with the support of a new dermatology sales force. In order to further expand sales of these approved products, Ligand has put in place a specialty dermatology sales force to focus on the sales of Targretin capsules, Targretin gel and Panretin gel among dermatologists, while reserving its specialty oncology sales representatives for the marketing of ONTAK, Targretin capsules and, upon approval, Morphelan(TM) among private practice oncologists. Research and development expenses decreased $8.2 million, or 14%, to $51.3 million for the year ended December 31, 2000, compared to $59.4 million for the year ended December 31, 1999. Decreased research and development expenses are primarily due to a reduction in clinical trial and NDA preparation activity related to Targretin capsules and Targretin gel. Selling, general and administrative expenses were $34.1 million for the year ended December 31, 2000, compared to $27.3 million in the same period in 1999, an increase of $6.8 million. The increases reflect additions in marketing and sales personnel, increased expenses for the launch and commercialization of Targretin capsules and Targretin gel, and the continued promotion of ONTAK and Panretin gel, partially offset by lower G&A expenses. During 2000, we implemented the SEC's Staff Accounting Bulletin number 101, a new accounting pronouncement that changed our method of revenue recognition for non-refundable up-front fees received in multiple-element contractual arrangements. SAB SAB Spontaneous abortion. See Abortion. 101 provides that non-refundable up-front fees received under collaborative and distribution agreements be recognized over the period of continuing involvement rather than upon payment. The cumulative effect of this change to December 31, 1999, resulted in a non-cash charge Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. to earnings of $13.1 million or $(0.24) per share for the year ended December 31, 2000. Following the adoption of SAB 101, the amortization of deferred up-front payments has been included in the caption "Collaborative Research and Development/Other" revenue and may be recognized in future quarters. In March 2001, the Company issued 412,504 shares of its common stock to Lilly as payment for a $5 million milestone due upon cumulative 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 ONTAK reaching $20 million, which was achieved in October 2000. Web Cast Conference Call Ligand Pharmaceuticals will host a live web cast, open to all interested parties, of a conference call during which David E. Robinson, Ligand Chairman, President and 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 Paul V. Maier, Senior Vice President and CFO See Chief Financial Officer. , will discuss financial results for 2000. The web cast will be available at http://www.streetevents.com and at http://www.ligand.com (Investor/Public Relations page) on Tuesday, March 20, 2001, at 8:30 a.m. Eastern Standard Time. Ligand Pharmaceuticals Incorporated Ligand Pharmaceuticals Incorporated 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, skin diseases, and men's and women's hormone-related diseases, as well as 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 , 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 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. (IRs) and Signal Transducers and Activators of Transcription (STATs STATs signal transducers and activators of transcription; a class of transcription factors that are activated in the cytosol following ligand binding to cytokine receptors. 'stats' A popular term for statistics. Cf 'Stat.'. ). This news release may contain certain 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. by Ligand which involve risks and uncertainties and reflect Ligand's judgement as of the date of this release. Actual events or results may differ from Ligand's expectations. There can be no assurance that Ligand will achieve quarterly break-even in 2001 or at all; collaborative arrangements will be successful or continued; Ligand will receive any milestone payments for the discovery and/or development of any compounds; any products under development by Ligand or any of its collaborative partners will receive approval from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or other authorities to market any of these products; if successfully developed and thereafter approved, there will be a market for the drugs. 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 website at http://www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Note: Targretin(R)and Panretin(R)are registered trademarks of Ligand Pharmaceuticals Incorporated, and ONTAK(R)is a registered trademark of Seragen, Inc., a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Ligand. Morphelan(TM)is a trademark of Elan. Full prescribing information for Ligand's products may be obtained in the U.S. from Ligand Professional Services (job) professional services - A department of a supplier providing consultancy and programming manpower for the supplier's products. by calling toll free 800-964-5836 or on Ligand's web site at http://www.ligand.com. Ligand Pharmaceuticals' releases are available on the World Wide Web at www.businesswire.com/cnn/lgnd.htm.
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED STATEMENTS OF OPERATIONS INFORMATION
(in thousands, except loss per share data)
Three Months Ended
December 31, Years Ended
(Unaudited) December 31,
2000 1999 2000 1999
Revenues:
Product sales $ 6,676 $ 2,180 $ 22,910 $11,307
Collaborative
research and
development/other 7,157 9,522 25,200 26,978
Contract
manufacturing -- 726 -- 2,610
Total revenues 13,833 12,428 48,110 40,895
Operating costs and
expenses:
Cost of products
sold 2,263 566 8,591 3,563
Contract
manufacturing -- 1,745 -- 6,926
Total product
and manufacturing
costs
2,263 2,311 8,591 10,489
Research and
development 12,794 14,644 51,287 59,442
Selling, general
and administrative 8,190 7,200 34,114 27,257
Write-off of
acquired
technology -- 5,000 -- 5,000
Total other
operating
expenses 20,984 26,844 85,401 91,699
Total operating
costs and
expenses 23,247 29,155 93,992 102,188
Loss from operations (9,414) (16,727) (45,882) (61,293)
Other expense, net (3,290) (6,134) (13,395) (13,426)
Loss before cumulative
effect of a change in
accounting principle (12,704) (22,861) (59,277) (74,719)
Cumulative effect on
prior years
(to December 31,
1999) of changing
method of revenue
recognition -- -- (13,099) --
Net loss $(12,704) $(22,861) $ (72,376) $(74,719)
Basic and diluted
per share amounts:
Loss before
cumulative effect
of a change in
accounting
principle $ (0.22) $ (0.48) $ (1.06) $ (1.58)
Cumulative effect
on prior years
(to December 31,
1999)of changing
method of revenue
recognition -- -- (0.24) --
Net loss $ (0.22) $ (0.48) $ (1.30) $ (1.58)
Weighted average
number of
common shares 56,642,265 47,938,845 55,664,921 47,146,312
Proforma amounts
assuming the new
revenue recognition
method is applied
retroactively:
Net loss $(12,704) $(22,644) $ (59,277) $(73,131)
Basic and
diluted net
loss per share $ (0.22) $ (0.47) $ (1.06) $ (1.55)
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED BALANCE SHEETS INFORMATION
(in thousands)
December 31,
2000 1999
Assets
Current assets:
Cash, cash equivalents,
investments and funds receivable $ 33,663 $ 47,155
Other current assets 10,986 9,524
Total current assets 44,649 56,679
Restricted investments 1,434 2,011
Property and equipment, net 10,972 20,542
Acquired technology, net 40,924 38,969
Other assets 15,443 16,444
$ 113,422 $ 134,645
Liabilities and Stockholders' Deficit
Current liabilities $ 28,415 $ 20,701
Zero coupon convertible senior notes 79,766 85,250
Convertible subordinated debentures 44,651 41,977
Other long-term liabilities 15,715 12,307
Stockholders' deficit (55,125) (25,590)
$ 113,422 $ 134,645
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