Friday, October 29, 2004

GSK'S Q3 EARNINGS NEGATIVELY IMPACTED BY GENERIC PAXIL, WELLBUTRIN COMPETITION; FIRM ON TRACK TO MEET 2004 GUIDANCE

GlaxoSmithKline Plc's third-quarter earnings were negatively affected by generic competition for depression therapies Paxil (paroxetine) and Wellbutrin (bupropion hydrochloride), but the pharmaceutical company said it is in line to meet its 2004 guidance.

For the period ended Sept. 30, GSK generated nearly $9.2 billion in sales, including $7.72 billion in pharmaceutical sales, compared with approximately $10 billion in total sales in the comparable period last year. Paxil sales totaled $450.7 million, a 51 percent decrease from the 2003 period, while Wellbutrin sales slid 30 percent to $316.9 million.

However, sales of GSK's asthma therapy Advair (fluticasone propionate/salmeterol) increased 20 percent during the period to $1.12 billion.

The company's net income, including taxes, reached $1.95 billion, or $0.34 per share, in this year's third quarter, down from $2.19 billion, or $0.38 per share, in the third quarter of 2003.

"These results confirm GSK's success in managing to absorb over $2.2 billion in lost sales to generic Paxil IR and Wellbutrin SR during the first nine months of the year and keeping overall pharmaceutical sales level," noted JP Garnier, GSK's chief executive.

"As the impact from Paxil generics now diminishes, we look forward to improved earnings growth in the fourth quarter and in 2005," Garnier added.

GSK shares closed at $42.31, down $0.34, or 0.8 percent, in moderate trading on the New York Stock Exchange.

Thursday, September 16, 2004

IN BRIEF: FOOD AND DRUG ADMINISTRATION

A Food and Drug Administration advisory panel concluded Wednesday that several drugs used to treat children with asthma, allergies and other conditions do not need stronger warnings included on their pharmaceutical labels. The drugs reviewed by the panel included GlaxoSmithKline Plc's Advair (fluticasone propionate and salmeterol xinafoate), Flonase (fluticasone propionate), Flovent (fluticasone propionate) and Cutivate (fluticasone propionate cream 0.05%); AstraZeneca Plc's Pulmicort (budesonide) and Rhinocort (budesonide); Schering-Plough Corp.'s Clarinex (desloratadine); Allergan Inc.'s Ocuflox (ofloxacin ophthalmic solution 0.3%); Berlex Inc.'s Fludara (fludarabine phosphate); and Merck & Co. Inc.'s Fosamax (alendronate sodium).

Wednesday, July 28, 2004

GSK'S SECOND-QUARTER PROFIT, NET INCOME DOWN

GlaxoSmithKline Plc reported a 13 percent decline in earnings during the second quarter of 2004 due to generic competition and a weak dollar.

Second-quarter 2004 pre-tax profit on a statutory basis was approximately $2.97 billion, or $0.37 per share, down from approximately $3.42 billion, or $0.44 per share, in the same quarter of last year.

Net income dropped from approximately $2.42 billion, or $0.41 per share, in the second quarter of 2003 to $2.11 billion, or $0.37 per share, in the latest quarter.

GSK attributed the overall decrease in profit to a weak U.S. dollar as well as increased generic naming competition in the United States for antidepressants Paxil (paroxetine hydrochloride) and Wellbutrin (bupropion hydrochloride).

Worldwide sales of asthma drug Advair Diskus (fluticasone propionate and salmeterol xinafoate) increased 22 percent to approximately $1.10 billion in the second quarter of 2004. Worldwide sales of diabetes drugs Avandia (rosiglitazone maleate) and Avandamet (metformin hydrochloride and rosiglitazone maleate) increased 59 percent to approximately $559.3 million.

Shares of GSK closed at $40.40, up $0.59, or 1.5 percent, in moderate trading on the New York Stock Exchange.

Friday, April 23, 2004

GSK'S ADVAIR DISKUS 100/50 MCG APPROVED FOR USE AMONG PEDIATRIC PATIENTS

The Food and Drug Administration approved the use of GlaxoSmithKline Plc's Advair Diskus 100/50 micrograms (fluticasone propionate and salmeterol inhalation power) as a long-term maintenance treatment for patients aged 4 to 11 years who have asthma and are symptomatic on inhaled corticosteroid therapy alone.

Advair, which contains an inhaled corticosteroid and a long-acting beta2-agonist, is designed to treat airway inflammation and bronchoconstriction. It is the only long-term preventative product that treats the two main components of asthma--airway inflammation and bronchoconstriction, according to GSK.

The product's safety profile was evaluated in 203 patients aged 4 to 11 years who had symptomatic asthma on low-dose inhaled corticosteroid. Twice-daily Advair 100/50 had a safety profile similar to that of twice-daily fluticasone propionate 100 mcg.

In addition, patients aged between 6 and 11 years who received Advair and those who received fluticasone propionate experienced improved lung function--measured by forced expiratory volume in one second--over the course of the study.

Advair has been available since April 2001 as a twice-daily, long-term maintenance treatment of asthma for patients aged 12 years or older.

Friday, August 15, 2003

IN BRIEF: THE FOOD AND DRUG ADMINISTRATION

The Food and Drug Administration said it will add new warnings to products containing salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease, after a small, but significant risk of life-threatening asthma episodes or asthma-related deaths was observed in patients taking the drug. GlaxoSmithKline Plc's Serevent inhalation aerosol, Serevent Diskus and Advair Diskus will be affected by the pharmaceutical label changes.

Thursday, May 1, 2003

GSK FIRST-QUARTER PROFIT RISES

First-quarter net earnings for GlaxoSmithKline Plc increased 23 percent this year, pushed by strong U.S. prescription drug sales.

The company reported business performance earnings of $2.02 billion, or $0.34 per share. In the year-ago quarter, earnings totaled $1.13 billion, or $0.30 per share.

Pre-tax profit rose 11 percent to $2.82 billion compared with $2.53 billion in the comparable quarter of last year. Analysts had expected pre-tax profit of $2.56 billion, according to Dow Jones.

Revenue in the first quarter increased to $8.30 billion from $8.13 billion in the year-ago quarter.

U.S. sales of prescription drugs increased 12 percent, boosted by a 71 percent increase in sales of asthma drug Advair (fluticasone and salmeterol).

For 2003, GSK reiterated that it expects "high single-digit percentage growth," assuming that generic competition is not introduced for its antidepressant Paxil (paroxetine). If a generic Paxil is introduced, the company said it will revise its earnings forecast.

Shares of GSK closed at $40.52, up $0.96, or 2.4 percent, in moderate trading on the New York Stock Exchange.