Ligand Reports Record Financial Results for Full Year and Fourth Quarter 2001; Product Sales Double for Year, Driving Total Revenues Up 59%.Business Editors & Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--March 11, 2002 Fourth Quarter 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. Down 73% Versus Prior Year; 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). Selects Avinza(TM) as Brand Name for Morphelan Morphelan® Pain management A proprietary formulation of morphine. See Morphine. (TM) Ligand Pharmaceuticals Incorporated (Nasdaq: LGND LGND Luminance Ground ) today reported total revenues for the year ended December December: see month. 31, 2001, of $76.3 million, compared to $48.1 million for the year 2000, an increase of 59%. Not including one-time one-time adj. 1. or one·time a. Occurring or undertaken only once: a one-time winner in 1995. b. charges for debt conversion expense and license fees, net loss for 2001 was $35.5 million ($0.60 per share). Including one-time charges of $7.5 million incurred in the fourth quarter of 2001, net loss for the year was $43.0 million ($.72 per share), representing an improvement of 41% (45% per share). For the fourth quarter ended December 31, 2001, total revenues were $22.6 million, compared to $13.8 million for the same period in 2000, an increase of 64%. Not including one-time charges, net loss for the fourth quarter of 2001 was $5.5 million ($0.09 per share), compared to a net loss of $12.7 million ($0.22 per share) for the same period in 2000, representing an improvement of 57% (59% per share). Including one-time charges of $7.5 million, net loss for the quarter was $13.1 million. "Ligand had an excellent year in 2001," 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, Senior Vice President and Chief Financial Officer. "We again showed robust overall revenue growth, driven by product sales that doubled to $45.6 million for the year. In particular, fourth quarter product sales were a record $15.6 million, a 134% increase over the fourth quarter of 2000 and a 37% increase over the third quarter of 2001, representing our tenth consecutive quarterly product sales increase. "We continued to experience moderation in the growth of our overall 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. , enabling us to cut annual operating losses in half, to $23.1 million. Our fourth quarter operating loss of $2.5 million was our smallest since we began commercial operations in 1999. We look forward to continued strong revenue growth during 2002 and further declines in operating losses, consistent with our goal of operating profitability for the full year." As of December 31, 2001, Ligand had 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 cash of $40.1 million, compared to $35.1 million at the end of 2000, an increase of 14%. "Our capital structure improved substantially in 2001 and early 2002 through the early conversion of $50 million ($61.8 million including accrued interest Accrued Interest The interest that has accumulated on a bond since the last interest payment up to but not including the settlement date. There are two methods for calculating accrued interest: 1) 360-day year method, used for corporate and municipal bonds. ) of zero-coupon convertible Zero-Coupon Convertible A zero-coupon bond issued by a corporation that can be converted into that corporation's common stock. Also known as a split coupon bond. Notes: notes," Maier said. "The early conversion eliminates $5.0 million of annual accretion The act of adding portions of soil to the soil already in possession of the owner by gradual deposition through the operation of natural causes. The growth of the value of a particular item given to a person as a specific bequest under the provisions of a will between the from these notes to non-operating expenses going forward, and enhances our ability to translate future operating profits Operating profit (or loss) Revenue from a firm's regular activities less costs and expenses and before income deductions. operating profit See operating income. into earnings per share." Detailed Results Net product sales for the full year and fourth quarter 2001 grew strongly across Ligand's product line:
2001 Sales % Growth vs. 4Q Sales % Growth vs.
(million) 2000 (million) 4Q 2000
------------ ------------ ------------ ------------
ONTAK(R) $24.3 84% $8.0 130%
Targretin(R)
capsules $14.6 118% $5.7 143%
Targretin gel and
Panretin(R) gel $6.6 156% $1.9 140%
------------ ------------ ------------ ------------
Total Net Product
Sales $45.6 99% $15.6 134%
Sales growth of ONTAK (denileukin diftitox denileukin diftitox /den·i·leu·kin dif·ti·tox/ (den?i-loo´kin dif´ti-toks) a genetically engineered construct combining amino acid sequences for specific diphtheria toxin fragments linked to sequences for interleukin-2 (IL-2); used as an ) was driven by increases in dose and number of treatment cycles, as well as by use in diseases other than cutaneous T-cell lymphoma Cutaneous T-Cell Lymphoma Definition Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system. Description (CTCL CTCL Cutaneous T Cell Lymphoma ). At year-end, an estimated 35% of ONTAK sales were originating from diseases including chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ), B- and T-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 , and severe 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 . Sales growth of Targretin (bexarotene bexarotene /bex·ar·o·tene/ (bek-sar´ah-ten) a retinoid used as an antineoplastic in the treatment of cutaneous T-cell lymphoma and the cutaneous lesions of T-cell lymphomas and Kaposi's sarcoma. ) capsules was driven by strong product acceptance among dermatologists and oncologists, and by increasing use in patients with earlier-stage CTCL. The strong growth of the gel products was due in part to the efforts of Ligand's specialty sales force focused on the unique needs of dermatologists. Fourth quarter sales of ONTAK and Targretin capsules were favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. affected by pre-price increase purchases and by initiation of wholesaler distribution stocking for ONTAK. Loss from operations was $23.1 million for 2001, compared to $45.9 million in 2000, an improvement of 50%. In the fourth quarter, loss from operations was $2.5 million, compared to $9.4 million in the same period of 2000, an improvement of 73%. Gross margin on product sales improved to 69% for 2001, compared to 63% in 2000. In the fourth quarter, gross margin was 72%, compared to 66% in the same period of 2000. As product sales continue to grow, gross margins could improve further (assuming constant product mix) as the technology amortization component of cost of sales declines as a percentage of sales. Research and development expenses were $51.1 million for 2001, compared to $51.3 million in 2000. In the fourth quarter, R&D expenses were $12.6 million, compared to $12.8 million in the same period of 2000. Selling, general and administrative expenses were $34.4 million for 2001, compared to $34.1 million in 2000. In the fourth quarter, SG&A expenses were $8.2 million, compared to $8.2 million in the same period of 2000. Operating expenses are expected to accelerate during 2002 to support the launch of Avinza (morphine sulfate morphine sulfate, n brand names: Duramorph PF, MS Contin, Roxanol; drug class: narcotic analgesic (Controlled Substance Schedule II); action: extended release, formerly Morphelan) and 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 Targretin capsules in non small-cell lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. . Highlights of Fourth Quarter 2001 and Early 2002
-- Ligand, Royalty Pharma Conclude Agreement for Rights/Options
Tied to Future SERM Royalty Streams
Royalty Pharma purchased from Ligand rights to a share of
future payments from Ligand's collaborative partners'
sales of three selective estrogen receptor modulator
(SERM) products now in Phase III development. Royalty
Pharma paid $6 million up front for a right to receive
0.25% of net sales of lasofoxifene, TSE-424 and
TSE-424/PREMARIN(R) for a period of 10 years. In total,
Royalty Pharma has options to purchase at escalating
prices rights to receive up to 1.25% of the products' net
sales for a total of $56 million. The transaction enables
Ligand, if options are exercised, to generate additional
near-term resources to accelerate development of our own
specialty pharmaceutical products.
-- Ligand Selects Avinza as Brand Name for Oral, Once-Daily
Sustained-Release Opioid Formerly Called Morphelan
Subject to final FDA approval of the NDA, Ligand expects
to commercialize its once-daily sustained release opioid
product under the brand name Avinza.
-- Two Avinza Clinical Studies Published in Peer-Reviewed
Journals
The first Avinza clinical study, published in Clinical
Therapeutics (Vol. 24, No. 2, 2002), showed that
sprinkling the entire contents of an Avinza capsule on
applesauce and swallowing without chewing is bioequivalent
to swallowing a capsule whole. The second study, published
in the Journal of Oncology Pharmacy Practice (Vol. 7,
2001), showed that Avinza once-daily provides more
consistent and stable plasma opioid concentrations than
OxyContin(R) (oxycodone hydrochloride controlled release)
twice-daily, while achieving comparably rapid opioid
release. Plasma levels do not necessarily translate to
clinical efficacy. A third Avinza study is pending
publication in The Journal of Applied Research.
-- New, Low-Dose ONTAK Regimen Demonstrates Activity in Severe
Psoriasis, Published Study Shows
Almost half (7/15) of patients with severe psoriasis who
were treated with a low-dose regimen of ONTAK had a
clinically meaningful response and fewer, less severe side
effects than patients in previous ONTAK studies, according
to a Phase II trial published in the December issue of the
Journal of the American Academy of Dermatology.
-- Marketing Authorization Application (MAA) for ONZAR Submitted
in Europe
Ligand received a $1 million milestone payment from
European marketing and distribution partner Elan for
submitting an application to market ONZAR (ONTAK in the
U.S.) for the treatment of cutaneous T-cell lymphoma
(CTCL).
-- New Clinical Data for ONTAK, Targretin Presented at American
Society of Hematology (ASH) Meeting
Treating CTCL patients with Targretin boosted the activity
of ONTAK and increased patient response rates in a pilot
phase I study presented by Tufts researchers at the annual
ASH meeting. In a second, related study, Tufts scientists
reported that in vitro, chronic lymphocytic leukemia (CLL)
cells that were exposed to bexarotene were more
susceptible to treatment with denileukin diftitox than
were cells treated with denileukin diftitox alone. And in
a third study, Wake Forest researchers reported for the
first time that ONTAK showed anti-cancer activity in
patients with fludaribine-refractory CLL.
-- Elan Converts $50 Million of Notes Into Ligand Stock
Elan converted three zero-coupon convertible notes with a
total original issue price of $50 million ($61.8 million
total value including accrued interest) into 4.4 million
shares of Ligand common stock. Ligand recognized a
one-time charge, arising from the agreement, of $5.0
million in the fourth quarter. From 2002 on, the
transaction eliminates $5.0 million of annual accretion
from these notes to Ligand's non-operating expenses.
-- Ligand Recognized for Contributions to Lymphoma Education,
Research and Treatment
Ligand received the third annual "Trailblazer Award" from
the Cure for Lymphoma Foundation for the company's three
new innovative lymphoma products and for its contributions
to lymphoma education, research and treatment.
Web Cast Conference Call Ligand 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 the fourth quarter and full year 2001. The web cast will be available at http://www.streetevents.com and at http://www.ligand.com (investor relations Investor relations The process by which the corporation communicates with its investors. page) on March 12 at 8:30 a.m. Eastern Standard Time. Ligand Pharmaceuticals Incorporated 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, skin diseases, men's and women's hormone-related diseases, 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 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. (IRs) and Signal Transducers and Activators of Transcription transcription /trans·crip·tion/ (-krip´shun) the synthesis of RNA using a DNA template catalyzed by RNA polymerase; the base sequences of the RNA and DNA are complementary. tran·scrip·tion n. (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.'. ). 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 certain forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These statements include those related to product sales and margins, operating expenses, the launch and commercialization of Avinza, studies of ONTAK (ONZAR), and the exercise of options by Royalty Pharma. Actual events or results may differ from Ligand's expectations. There can be no assurance that Ligand will increase revenues or margins from currently marketed products or reduce operating losses; that Ligand will be able to achieve its goal of operating profitability; that the results from the periods discussed in this release will be indicative of results for future periods; that results of any clinical study will be confirmed by later studies; that Avinza or any other products under development by Ligand or any of its collaborative partners will receive marketing approval; that there will be a market for the drugs if successfully developed and thereafter approved; that collaborative arrangements will be successful or continued; that Royalty Pharma will exercise any options; or that Ligand will receive any milestone payments for the discovery and/or development of any compounds. 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 http://www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Note: Ligand(R), Targretin(R), Panretin(R), Avinza(TM), ONTAK(R) and ONZAR(TM) are trademarks of Ligand Pharmaceuticals Incorporated. Morphelan(TM) is a trademark of 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]. . Other trademarks are the property of their owners. 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
(in thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
(Unaudited)
------------------ ----------------
2001 2000 2001 2000
---- ---- ---- ----
Revenues:
Product sales $ 15,608 $ 6,676 $ 45,623 $ 22,910
Collaborative research
and development and
other revenues 7,035 7,157 30,718 25,200
-------- -------- -------- --------
Total revenues 22,643 13,833 76,341 48,110
-------- -------- -------- --------
Operating costs and
expenses:
Cost of products sold 4,386 2,263 13,947 8,591
Research and development 12,626 12,794 51,104 51,287
Selling, general and
administrative 8,178 8,190 34,427 34,114
-------- -------- -------- --------
Total operating costs
and expenses 25,190 23,247 99,478 93,992
-------- -------- -------- --------
Loss from operations (2,547) (9,414) (23,137) (45,882)
-------- -------- -------- --------
Other expense:
Interest expense, net (2,894) (2,732) (11,495) (10,545)
Debt conversion expense (5,043) -- (5,043) (2,025)
Other, net (2,571) (558) (3,320) (825)
-------- -------- -------- --------
Total other expense,
net (10,508) (3,290) (19,858) (13,395)
-------- -------- -------- --------
Loss before cumulative
effect of a change in
accounting principle (13,055) (12,704) (42,995) (59,277)
Cumulative effect on prior
years (to December 31,
1999) of changing method
of revenue recognition -- -- -- (13,099)
-------- -------- -------- --------
Net loss $(13,055) $(12,704) $(42,995) $(72,376)
======== ======== ======== ========
Basic and diluted per
share amounts:
Loss before cumulative
effect of a change in
accounting principle $ (0.22) $ (0.22) $ (0.72) $ (1.06)
Cumulative effect on
prior years (to December
31, 1999) of changing
method of revenue
recognition -- -- -- (0.24)
-------- -------- -------- --------
Net loss $ (0.22) $ (0.22) $ (0.72) $ (1.30)
======== ======== ======== ========
Weighted average number
of common shares
outstanding 59,747 56,642 59,413 55,665
======== ======== ======== ========
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, December 31,
2001 2000
------------ ------------
Assets
Current assets:
Cash, cash equivalents and short-term
investments $ 37,688 $ 33,663
Other current assets 15,886 10,986
--------- ---------
Total current assets 53,574 44,649
Restricted investments 2,370 1,434
Property and equipment, net 9,690 10,972
Acquired technology, net 37,879 40,924
Other assets 13,960 15,443
--------- ---------
$ 117,473 $ 113,422
========= =========
Liabilities and Stockholders' Deficit
Current liabilities $ 31,726 $ 28,415
Zero-coupon convertible senior notes 86,078 79,766
Convertible subordinated debentures 47,326 44,651
Other long-term liabilities 10,218 15,715
Stockholders' deficit (57,875) (55,125)
--------- ---------
$ 117,473 $ 113,422
========= =========
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