Ligand Updates AVINZA Launch Progress, Revises Second Quarter Revenue Guidance, and Reiterates Full-Year Revenue Guidance with Different Product Sales Mix.Business Editors & Health/Medical Writers BIOWIRE2K Product Mix Adjustments Reflect Reduced Wholesaler Purchases in Second Quarter, Softer Than Expected Demand Growth for ONTAK(R) and Targretin(R) 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 ) announced today the full, national launch of its fifth product, AVINZA(TM), by the company's 80-person sales force to approximately 9,000 physicians during the second quarter. AVINZA (morphine sulfate morphine sulfate, n brand names: Duramorph PF, MS Contin, Roxanol; drug class: narcotic analgesic (Controlled Substance Schedule II); action: extended-release capsules) is indicated for the once-daily treatment of chronic, moderate-to-severe pain in patients who require continuous, around-the-clock opioid opioid /opi·oid/ (o´pe-oid) 1. any synthetic narcotic that has opiate-like activities but is not derived from opium. 2. any of a group of naturally occurring peptides, e.g. therapy for an extended period of time. "Launching AVINZA into a multibillion-dollar market is a major milestone in Ligand's commercial evolution into a high-growth specialty pharmaceutical company," said Thomas Silberg, executive vice president and chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Ligand. "We are launching AVINZA with a highly motivated, well-trained sales force with full scientific promotional materials, supported at launch by five peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. articles that confirm the product's clinical value in large-scale clinical trials and pharmacokinetic studies. In addition, managed care organizations have responded very favorably to the attributes of AVINZA, and we expect the product to enjoy rapid, significant 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. acceptance." The initial stocking of AVINZA in retail pharmacies by wholesalers has proceeded well, thus facilitating product availability for chronic pain patients. Ligand's initial shipments to wholesalers were $11.5 million, approximately $4 million of which is expected to be included in second-quarter product sales. The goal of the first round of shipments is to quickly expand retail availability for patients to 10,000 pharmacies. All of these pharmacies are receiving one bottle each (1 x 100 capsules) of the 30 and 60 mg. strengths of AVINZA, and up to 5,000 of them also are expected to receive the 90 and 120 mg. strengths. A second round of shipments is expected to begin during the third quarter. These shipments should expand distribution of all doses to up to an additional 5,000 pharmacies, bringing to 15,000 the number of pharmacies stocking the 30 and 60 mg. doses, and to 10,000 the number of pharmacies stocking all four doses. Depending upon the rate of prescription uptake, a third round of shipments to reach an additional 5,000 pharmacies is planned for as early as the fourth quarter. Based on the progress of the initial retail distribution program, positive progress in managed care formulary availability for this year, and recent positive market research and physician interest, Ligand is increasing its guidance for 2002 AVINZA sales to approximately $30 million. Ligand does not expect definitive prescription demand curve trends to be clear until eight to 10 weeks after launch, although the company will be tracking new prescriptions regularly toward its goal of 30,000-50,000 prescriptions this year (in a market of more than 12 million prescriptions). Ligand continues to make progress in its co-promotion discussions with Elan, and is working to complete these discussions as early as possible in the third quarter. Ligand Revises Second Quarter Revenue Guidance, Reiterates Full-Year Guidance of $82-90 Million with Different Product Sales Mix sales mix See product mix. In the second quarter, Ligand's product sales were negatively affected by approximately $6-8 million at quarter-end by several major wholesalers' decisions not to purchase, or to purchase reduced quantities of, our marketed products, as well as by lower-than-expected demand growth during the second quarter. The lower-than-expected demand growth was due primarily to delays in completion and data publication of key ongoing, expanded-use clinical trials in B-cell NHL NHL Non-Hodgkin's lymphoma, see there and CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid , and to delays in the initiation of new, expanded use physician-initiated trials in a number of key indications for ONTAK(R) (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 ) and Targretin(R) (bexarotene) capsules. Ligand has assessed current and future wholesaler inventories of its specialty products, and the impact of slower demand growth in the second quarter, on expected sales growth of ONTAK and Targretin in the second half of 2002. Compared to 2001, prescription growth has been positive in 2002 for Ligand's existing products, with the exception of Panretin(R) gel. However, based on its second-quarter experience to date, Ligand believes overall growth trends will be lower than expected in 2002 for products other than AVINZA. As a result, the company is revising its fiscal 2002 guidance for worldwide sales of its existing products, excluding AVINZA, to the range of $50-55 million, with no change to the full-year guidance including AVINZA. "Although we are disappointed with product sales in the second quarter, we are pleased to reaffirm our previous guidance for the full year based on the strong launch of AVINZA," Mr. Silberg said. "Specifically, we continue to expect to roughly double product sales in 2002 to between $82 and $90 million." With the release of Ligand's second-quarter financials at the end of July, the company expects to provide additional guidance on expenses, which were lower than expected in the first quarter, and on the impact, if any, of changes in product sales mix on gross margins and fiscal 2002 EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. guidance. Other Events Ligand also announced that it has formally withdrawn its European Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) for Targretin gel in early-stage CTCL CTCL Cutaneous T Cell Lymphoma . Due to the small size of the European CTCL market and the limited revenue potential of Targretin gel, Ligand believes that the additional comparative clinical studies requested by the EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. could not reasonably be conducted prior to approval and were not economically justified. Ligand has recently completed a Phase I/II trial of Targretin gel in 55 U.S. patients with hand dermatitis dermatitis (dûr'mətī`tĭs), nonspecific irritation of the skin. The causative agent may be a bacterium, fungus, or parasite; it can also be a foreign substance, known as an allergen. and is analyzing the data. Ligand believes that if this data is positive, a combined U.S./European development program in this large dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. market would be a faster and more economically attractive investment, enabling resubmission in Europe for the potential new indication. Targretin capsules are approved and being launched in Europe for CTCL, and Ligand regrets that European cancer patients will not benefit from the gel product's availability, as a growing number of patients do 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. . Separately, the company announced it has completed a resale registration (on form S-3) for the shares of its common stock sold to institutional investors in a private placement in April 2002, following a full review of the registration statement by the Securities and Exchange Commission, including review of Ligand's 2001 10-K and first quarter 2002 10-Q reports and financial results. About Ligand Ligand discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, men's and women's hormone-related diseases, osteoporosis, metabolic disorders, and cardiovascular and inflammatory diseases. 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 (IRs) and Signal Transducers and Activators of Transcription (STATs). Web Cast Conference Call Ligand will host a live web cast, open to all interested parties, of a conference call during which senior management will discuss this news release. The web cast will be available at www.streetevents.com and www.ligand.com (investor relations Investor relations The process by which the corporation communicates with its investors. page) at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) Wednesday, July 10, and will be archived for 30 days. Ligand Pharmaceuticals' releases are available on the World Wide Web at www.businesswire.com/cnn/lgnd.htm. Caution Regarding Forward-Looking Statements This news release contains 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 AVINZA sales, shipments, pharmacy stocking, retail availability and distribution; formulary acceptance, market research, physician interest, guidance and co-promotion discussions; wholesaler inventories, demand and prescription growth; ONTAK, Targretin and general product sales and total revenue growth and guidance; Targretin gel clinical trials and development, market size and MAA resubmission. Actual events or results may differ from Ligand's expectations. For example, we may not be able to successfully market and supply AVINZA or the other products mentioned and sales may not meet our guidance and expectations. We may not be able to conclude a favorable co-promotion arrangement with Elan. Sales and supplies of other products may likewise not meet our expectations due to a number of factors including doctor prescribing, wholesaler purchasing patterns and supplier operations. Clinical trials may not produce favorable results and marketing applications may not be approved. 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 the company's internet site at 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. |
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