Friday, August 6, 2004

KOS PHARMACEUTICALS ACHIEVES 245 PERCENT INCREASE IN EARNINGS, 85 PERCENT INCREASE IN REVENUE DURING SECOND QUARTER; RAISES FISCAL 2004 GUIDANCE

Kos Pharmaceuticals Inc. recognized a 245 percent increase in net income and an 85 percent increase in revenue in the second quarter of 2004 due to sales growth of its cholesterol products and "excellent control" of operating expenses.

In the quarter, the firm's net income reached $38.5 million, or $0.83 per diluted share, compared with $11.2 million, or $0.31 per share, in the comparable period of last year. Kos attributed the improvement to robust revenue growth, efficient management of operating expenses and the receipt of a one-time payment of $6 million from Andrx Laboratories Inc. as part of a resolution of a trademark infringement lawsuit.

Revenue in the quarter totaled $120.3 million, up from $64.9 million in the second quarter of 2003. The increase in revenue was driven by strong performance of the company's proprietary brand name drugs, Niaspan (niacin) and Advicor (lovastatin/extended-release niacin), for cholesterol therapies. Additionally, Kos benefited from initial-quarter revenue from its newly purchased asthma therapy Azmacort (triamcinolone acetonide).

In March, Kos purchased the Azmacort product line and its pharmaceutical brand name from Aventis SA in a $200 million, all-cash transaction. Azmacort is an inhaled corticosteroid indicated as a prophylactic therapy for asthma maintenance in patients aged 6 years or older. It is also indicated to reduce or eliminate the need for systemic corticosteroids in patients who require such treatment.

As a result of its strong performance in this year's second quarter, the pharmaceutical company increased its fiscal-year earnings-per-share guidance to between $2.60 and $2.65, while revenue is expected to reach approximately $480 million, a 60 percent increase from 2003.

Kos shares closed at $34.61, up $5.86, or 20.3 percent, in heavy trading on the Nasdaq.

INITIAL THERAPY WITH ADVICOR ASSOCIATED WITH GOOD COMPLIANCE, SAFETY AMONG DYSLIPIDEMIA PATIENTS, DATA INDICATE

Kos Pharmaceuticals Inc.'s Advicor (lovastatin/extended-release niacin), given as an initial therapy, is associated with good patient compliance and safety, and low incidences of increased liver and muscle enzymes in patients with dyslipidemia, according to a recent study.

Researchers enrolled 4,499 patients with dyslipidemia who required drug intervention into the trial. Patients were administered one Advicor tablet (lovastatin 20 mg/extended-release niacin 500 mg) once nightly for four weeks and then two tablets for a period of eight weeks.

The pharmaceutical research team defined the trial's primary endpoints as overall patient compliance, increases in liver transaminases to greater than three times the upper limit of normal and clinical myopathy. Final study data are available for 4,217 patients.

Results showed that 77 percent of Advicor recipients were compliant with the treatment regimen, with 3,245 patients completing the trial. Patients in the southeast and those enrolled in the trial by endocrinologists were observed to have the lowest levels of compliance and the highest rates of adverse events.

Flushing was the most frequent adverse event, reported by 18 percent of Advicor-treated patients, and led to discontinuation by 6 percent. Increased levels of aspartate aminotransferase and/or alanine aminotransferase to greater than three times the upper limit of normal occurred in less than 0.3 percent of patients who received the therapy.

Furthermore, 0.24 percent of patients experienced an increase in creatine phosphokinase levels to greater than five times the upper limit of normal.

This study was published in the Aug. 1 issue of the American Journal of Cardiology.

Thursday, June 3, 2004

ADVICOR ACHIEVES DESIRED CHOLESTEROL LEVELS MORE EFFECTIVELY, AT LOWER COST THAN ZOCOR, NEW ANALYSIS DEMONSTRATES

Kos Pharmaceuticals Inc.'s healthcare brand name drug Advicor (lovastatin and extended-release niacin) is more effective and less costly than Merck & Co. Inc.'s healthcare brand name drug Zocor (simvastatin) for adults trying to reach an LDL cholesterol goal of less than either 100 mg/dL or 130 mg/dL and an HDL cholesterol goal of 40 mg/dL or more, new data show.

Researchers created decision-analytic models for different patient populations that required LDL goals of less than 160 mg/dL, less than 130 mg/dL or less than 100 mg/dL and compared the ability and costs of Advicor and Zocor to achieve the goals. The cholesterol levels were obtained from the Third National Health and Nutrition Examination Survey.

For both the 130 mg/dL and 100 mg/dL analyses, Advicor had higher success rates and lower estimated direct medical costs compared with Zocor.

Zocor had the highest clinical success rate for patients who required an LDL goal of less than 160 mg/dL and an HDL goal of 40 mg/dL or more. However, in this scenario, which only a minority of patients requires, Zocor was nearly twice as expensive as Advicor ($665 vs. $333).

The analysis appears in the May/June edition of the Journal of Managed Care Pharmacy.

Wednesday, May 26, 2004

EXTENDED RELEASE NIACIN/LOVASTATIN TABLET IMPROVES FOUR LIPOPROTEIN LEVELS, STUDY SHOWS

Combination therapy with extended-release (ER) niacin/lovastatin substantially lowers LDL cholesterol, triglyceride and lipoprotein levels while raising HDL cholesterol levels, a new study shows. Kos Pharmaceuticals Inc. markets the niacin ER/lovastatin tablet known as the pharmaceutical brand name drug, Advicor.

The study involved 85 men and 79 women with type IIa or IIb primary hyperlipidemia after diet. Patients were randomized into five treatment arms: niacin ER alone, lovastatin monotherapy and three combination arms, each with a constant lovastatin dose and escalating niacin ER doses.

For primary comparisons, mean LDL cholesterol level reductions from baseline were greater with niacin ER/lovastatin (1,500/20 mg) than with lovastatin (20 mg; 35 percent vs. 22 percent) and with niacin ER/lovastatin (2,000/40 mg) than with lovastatin (40 mg; 46 percent vs. 24 percent).

In addition, the study showed a 4 percent decrease in LDL levels and an 8 percent increase in HDL levels, on average, with each 500-mg increase in niacin ER.

The maximum recommended dose (2,000/40 mg per day) of niacin ER/lovastatin increased HDL levels by 29 percent and decreased LDL levels by 46 percent, triglyceride levels by 38 percent and lipoprotein levels by 14 percent, the researchers wrote.

The study appears in the May 24 issue of the Archives of Internal Medicine.

Friday, August 1, 2003

Q2 REPORT, REVISED FY EARNINGS PROJECTION SEND KOS SHARES SOARING

Kos Pharmaceuticals Inc. shares surged 26.4 percent after the drug maker posted a profit in the second quarter as a result of solid sales growth for two cholesterol drugs.

In the second quarter of 2003, Kos earned $11.2 million, or $0.31 per diluted share, compared with a net loss of $10.3 million, or $0.50 per share, in the year-ago quarter.

Quarterly revenue totaled $64.9 million in the period, a 70 percent increase from $38.3 million in the second quarter of 2002. In particular, sales of healthcare brand name cholesterol drugs Advicor (niacin and lovastatin) and Niaspan (niacin) grew approximately 200 percent and 51 percent, respectively.

As a result of the positive second-quarter results, Kos now anticipates earning between $1.20 per share and $1.30 per share in 2003, up from its previous projection in the range of $0.65 per share to $0.75 per share.

Kos said it expects to launch Niaspan in the United Kingdom during the fourth quarter of 2003 and in other major European markets in 2004.

Shares of Kos closed at $34.14, up $7.13, in heavy trading on the Nasdaq.

Wednesday, May 7, 2003

KOS ACHIEVES PROFITABILITY FOR SECOND CONSECUTIVE QUARTER

Kos Pharmaceuticals Inc. announced first-quarter earnings of $12.7 million, behind strong growth of two of its cholesterol-reducing pharmaceutical brand name drugs, sending the company's shares up 13.2 percent.

Earnings per share rose to $0.35, improving upon last year's first-quarter loss of $0.79 per share, or $16.2 million.

Excluding special items, Kos' earnings reached $2.2 million, or $0.08 per share--$0.27 better than the Reuters Research consensus estimate of a loss of $0.19 per share.

The pharmaceutical company reported a 101 percent increase in revenue to $68.3 million from $33.9 million in last year's first quarter, reflecting the productivity of its lead product, Niaspan (niacin), and its newer cholesterol pharmaceutical brand name drug, Advicor (niacin and lovastatin).

Niaspan sales accounted for $53 million in revenue this quarter, an increase of 78 percent from the previous year. Advicor, one year removed from its introduction to the market, generated $15.3 million in revenue, a 273 percent increase from the first quarter of 2002.

The company estimated that its overall revenue for 2003 will increase approximately 60 percent from the previous year. Enhanced profitability is also expected, with projected earnings between $0.65 per share and $0.75 per share.

Shares of Kos closed at $23.75, up $2.77, in heavy trading on the Nasdaq.