Wednesday, January 19, 2005

FOREST LABORATORIES REPORTS 15 PERCENT RISE IN THIRD-QUARTER PROFIT

Forest Laboratories Inc. reported a 15 percent increase in net income for its fiscal third quarter, which ended Dec. 31, 2004.

Net income rose to $260.8 million, or $0.70 per share, up from $226.1 million, or $0.60 per share, in the third quarter of 2003. The company forecast earlier this month that earnings would be approximately $0.68 per share. Revenue rose to $832.2 million for the quarter from $707.2 million in the comparable quarter.

Quarterly net sales increased 14 percent to $795 million from $700.5 million in the previous-year period. Sales of Forest's antidepressants totaled $560.6 million, down 5 percent from $587.9 million in the third quarter of 2003. The company attributed the drop in antidepressant sales to the introduction of generic versions of pharmaceutical brand Celexa (citalopram HBr) during the quarter.

Sales of the antiviral Flumadine (rimantadine hydrochloride) for the third quarter were boosted by the U.S. government's one-time purchase of $33.5 million of the drug, resulting from last fall's flu vaccine shortage. Total third-quarter sales of Flumadine were $34.6 million. Namenda (memantine hydrochloride), an N-methyl-D-aspartate (NMDA) receptor antagonist used to treat moderate to severe Alzheimer's disease, had quarterly sales of $100.6 million.

Howard Solomon, Forest's chief executive officer, said the company expects fiscal year 2004 earnings of approximately $2.60 per share.

Shares of Forest closed at $41.79, down $0.38, or 0.9 percent, in heavy trading on the New York Stock Exchange.

Wednesday, November 3, 2004

FOREST REVISES FULL-YEAR EARNINGS GUIDANCE TO REFLECT GENERIC CELEXA COMPETITION; LERCANIDIPINE FAILS TO MEET ALL TARGETS IN PHASE II HYPERTENSION TRIAL

Forest Laboratories Inc. lowered its 2004 fiscal year earnings guidance for the 12 months ended March 31, 2005, due to the launch of several generic forms of its pharmaceutical brand antidepressant Celexa (citalopram hydrobromide).

The company now expects to earn $2.50 per diluted share in 2005 compared with diluted earnings per share of $1.95 in fiscal 2004. In October, the company said it expected to earn "at least $2.70" per share in the full year. Forest noted it does not expect to make any operational changes as a result of the launch of generic Celexa versions.

Last Thursday, three generic manufacturers, including Forest's generic division, Inwood Laboratories, received approval from the Food and Drug Administration to market generic formulations of Celexa. The approval was granted several months ahead of what analysts had expected, TheStreet.com reported.

Separately, Forest provided an update on the clinical development of its investigational compound lercanidipine, which is being examined as a potential treatment for hypertension.

In response to an August 2002 request from the Food and Drug Administration for additional data on lercanidipine, the company conducted an eight-week Phase II trial of approximately 60 patients. Subjects were administered once-daily lercanidipine in an experimental modified-release formulation.

Preliminary results showed that while the modified-release version was associated with a clinically relevant reduction in blood pressure, results did not meet all pre-determined criteria for dose response across the range of doses examined.

Forest licenses lercanidipine from Italy-based Recordati SpA.

Shares of Forest closed at $42.00, down $2.10, or 4.8 percent, in heavy Wall Street trading.

Thursday, September 9, 2004

FOREST LABORATORIES TO CREATE ONLINE CLINICAL TRIAL REGISTRY

As part of an agreement reached with New York State Attorney General Eliot Spitzer, Forest Laboratories Inc. said it will create a public, online Clinical Trial Registry of Forest-sponsored clinical studies completed since January 2000 that involve currently marketed drugs.

As a result, Spitzer has agreed to end his inquiry into the firm's study disclosure practices, Forest added.

By Dec. 31, 2005, the firm intends to post to the registry summaries of all Phase III and IV studies that were sponsored by Forest, completed since Jan. 1, 2000, and involved a drug that is currently marketed. The firm noted that the Web site will include summaries from clinical studies in which pediatric patients received its depression drug Celexa (citalopram hydrobromide) or major depressive disorder and generalized anxiety disorder drug Lexapro (escitalopram oxalate).

For any Phase III trials completed after Sept. 7, 2004, Forest intends to post the summary results to the registry once the product is commercially introduced in the United States. Moreover, Forest plans to post summaries of Phase IV trials completed after Sept. 7 within a year of completion.

Once the firm initiates a new Phase III or IV trial, Forest will post the trial number, title, start date and key objectives to the registry.

Additionally, the Web site will include summaries for both Phase I and II trials completed after January 2000 and for studies completed before that date that "provide additional important information for physicians and the care of patients."

Tuesday, August 17, 2004

IN BRIEF: FOREST LABORATORIES INC.

Forest Laboratories Inc.'s patent for its antidepressant Celexa (citalopram hydrobromide) was upheld Monday after a federal judge dismissed a challenge presented by Australia-based Alphapharm Pty. Ltd., Reuters reported. The judge ruled that the Food and Drug Administration, in a prior judgment, "properly refused" the Australian company's application to market a generic version of Celexa.

Wednesday, April 21, 2004

FOREST ANNOUNCES FISCAL FOURTH QUARTER, YEAR RESULTS; PROVIDES FORECAST

Forest Laboratories Inc. reported financial results for its fiscal fourth quarter and twelve months ended March 31.

In the fourth quarter, Forest's net sales increased 17 percent to approximately $725.1 million, up from $621.1 million in the comparable period in 2003. Sales during this year's first quarter included nearly $597.5 million for its antidepressant franchise, which comprised $351.8 million for Lexapro (escitalopram oxalate) and $245.7 million for Celexa (citalopram hydrobromide).

Net income fell 20 percent to $145.5 million, or $0.38 per share, in the fourth quarter. The company said selling, general and administrative expenses climbed 50 percent to $298.1 million due to an expansion of its sales force and launch expenses for Alzheimer drug Namenda (memantine hydrochloride) and Lexapro for the generalized anxiety disorder indication. Furthermore, research and development costs jumped 57 percent to $80.7 million in the quarter.

For the fiscal year ended March 31, net sales increased 20 percent to approximately $2.65 billion compared with $2.21 billion in the comparable period. Forest's net income reached approximately $735.9 million, an 18 percent jump from nearly $622 million in the prior year.

"At this time, we expect that our projected spending levels in support of both currently promoted and development products, continued market share gains for our key products and the entry of generic versions of Celexa are likely to result in earnings per share for the fiscal year ending March 31, 2005 in the range of $2.35 to $2.50," said Howard Solomon, Forest's chairman and chief executive.

Forest shares closed at $69.69, down $1.88, or 2.6 percent, in heavy trading on the New York Stock Exchange.

Wednesday, March 24, 2004

FDA ISSUES HEALTH ADVISORY REGARDING POSSIBLE RISK OF SUICIDAL IDEATION IN PATIENTS ON ANTIDEPRESSANTS

The Food and Drug Administration issued a Public Health Advisory recommending that physicians, families and caregivers closely monitor patients with depression at the beginning of treatment and when a treatment dose is changed.

More specifically, patients should be monitored for certain behaviors that have been associated with antidepressants, including anxiety, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness) and mania. Physicians should be especially vigilant about observing these behaviors among patients who may have bipolar disorder, the agency added.

Additionally, the regulatory agency asked the manufacturers of 10 antidepressants to alter their labels to include stronger warnings about the need to monitor patients with worsening depression and/or the emergence of suicidal ideation.

"Although FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy," the advisory stated.

Beginning in June 2003, initial reports were released from clinical studies that suggest there may be an increased risk of suicidal thoughts and actions among children treated with certain antidepressants, although no suicides occurred during the trials. It was unclear whether certain behaviors that occurred during the studies were actual suicide attempts or self-injurious behaviors that were not suicide-related.

Since that time, the FDA has employed experts to fully review these reports, but it is still unclear whether antidepressants contribute to the emergence of suicidal thoughts and behavior, the agency noted.

The drugs under review include GlaxoSmithKline Plc's Wellbutrin (bupropion hydrochloride) and Paxil (paroxetine hydrochloride), Forest Laboratories Inc.'s Celexa (citalopram hydrobromide) and Lexapro (escitalopram oxalate), Eli Lilly and Co.'s Prozac (fluoxetine hydrochloride), Solvay Pharmaceuticals Inc.'s Luvox (fluvoxamine maleate), Organon N.V.'s Remeron (mirtazapine), Bristol-Myers Squibb Co.'s Serzone (nefazodone hydrochloride), Pfizer Inc.'s Zoloft (sertraline) and Wyeth's Effexor (venlafaxine hydrochloride).

Only Prozac is approved for use in children with major depressive disorder, while Zoloft, Prozac and Luvox are approved for treating pediatric patients with obsessive compulsive disorder. Luvox has not been approved by the FDA as an antidepressant.

The Public Health Advisory follows recommendations made last month by the Psychopharmacologic Drugs and Pediatric Subcommittee of the FDA's Anti-Infective Drugs Advisory Committees. The regulatory agency plans to update the committees this summer on the results of the expert analyses and its own analyses of the pediatric suicidality data.

Wednesday, July 16, 2003

FOREST REPORTS Q1 EARNINGS GROWTH, WARNS MAY MISS FY EPS TARGET

Forest Laboratories Inc. reported sharp earnings growth for the first quarter of fiscal 2004 but warned that it may not achieve its earnings-per-share growth target of 20 percent for the fiscal year, causing a 9.4 percent drop in the company's share value.

In the first quarter, Forest earned $179.8 million, or $0.48 per diluted share, reflecting a 45 percent increase from $123.8 million, or $0.33 per share, in the first quarter of 2003. Results were in line with analysts' projections of $0.48 per share, according to Reuters Research.

Quarterly net revenue totaled $614.4 million in 2004 compared with $478.8 million in the prior-year period.

New York-based Forest said its share of the antidepressant market increased during the quarter. Lexapro (escitalopram) amassed quarterly sales totaling $191 million, offsetting declining sales of Forest's older product, Celexa (citalopram), which had sales of $248.7 million in the quarter.

"Marketshare targets for our antidepressant franchise are being achieved, although the overall growth rate in prescriptions for the major therapeutic categories in the U.S. pharmaceutical industry, including the SSRI category, declined during the quarter, perhaps due to overall economic conditions," said Forest Chief Executive Officer Howard Solomon.

Forest warned that it if this trend continues, the company may fall short of its 2004 earnings-per-share growth target of 20 percent.

Shares of Forest closed at $49.25, down $5.08, in heavy trading on the New York Stock Exchange.

Wednesday, April 23, 2003

FOREST LABORATORIES SHARES FALL AS COMPANY MISSES EARNINGS TARGET

Shares of Forest Laboratories Inc. tumbled 5.9 percent after the pharmaceutical manufacturer's fourth-quarter and full-year earnings and revenue fell short of analysts' expectations.

Fourth-quarter net income increased 87 percent in 2003 to $180.7 million, or $0.48 per diluted share, compared with $96.6 million, or $0.26 per share, in the prior-year period. According to First Call Corp., analysts, on average, had forecast earnings of $0.49 per share for the quarter.

Fourth-quarter revenue totaled $621.1 million in 2003 compared with $436.8 million in 2002. The 42 percent jump in quarterly sales was based primarily on increased sales of the firm's antidepressant products, Celexa (citalopram) and Lexapro (escitalopram). Together, the products generated $484.9 million in sales during the quarter.

Forest earned $622 million, or $1.66 per share, in the full year 2003, reflecting an 84 percent increase from $338 million, or $0.91 per share, in 2002.

Full-year net sales totaled $2.21 billion in 2003 compared with $1.57 billion last year.

Forest shares closed at $49.40, down $3.07, in heavy trading on the New York Stock Exchange.