Generics cuts 2Q sales, profit for Bristol-Myers

TRENTON, N.J. (AP) -- Generic competition for one-time blockbuster drugs at Bristol-Myers Squibb Co. continues to hurt the pharmaceutical company, driving both revenue and profit down sharply in the second quarter.

Big sales jumps for some newer medicines and, by a fluke, a zero net tax rate, enabled Bristol-Myers to meet Wall Street's diminished expectations, but the New York company on Thursday lowered its profit forecast significantly for the year.

The maker of antipsychotic drug Abilify and Orencia for rheumatoid arthritis said its net income in the quarter was $536 million, or 32 cents per share. That was down 17 percent from $645 million, or 38 cents per share, a year earlier.

Revenue fell by 9 percent, from $4.44 billion to $4.05 billion. That was just above the $4.04 billion, on average, expected by analysts surveyed by FactSet.

Excluding one-time items totaling $194 million, or 12 cents per share, the company posted adjusted net income of $730 million, or 44 cents per share.

Still, Bristol's sales are tracking to come in far lower this year than their 2011 peak of $21.24 billion. That was shortly before the company got hammered by generic competition to heart attack- and stroke-preventing pill Plavix, which had been the world's second-bestselling drug. It was the same story for its blood pressure drugs Avapro and Avalide.

Together, those drugs turned into more than $8 billion in sales for Bristol-Myers in 2011. But by the second quarter of this year, Plavix sales all but disappeared, totaling $44 million. Avapro and Avalide fell to $56 million in sales. That combined $100 million is one-80th of the sales rate logged just 18 months.

Newer drugs picked up some of the slack, with sales of Orencia up 21 percent at $352 million, leukemia drug Sprycel up 28 percent at $312 million, melanoma drug Yervoy up 44 percent at $233 million and Type 2 diabetes pills Onglyza and Kombiglyze up 40 percent to a combined $240 million. But sales of Abilify, now the company's top seller, dropped 21 percent to $563 million.

In February, Bristol-Myers and partner Pfizer Inc. launched Eliquis, their entry in the highly competitive category of new pills used to prevent heart attacks and strokes. They're meant to supplant the longtime standard treatment, blood thinner warfarin, which is cheap but requires frequent blood tests to keep the dose right and prevent dangerous internal bleeding.

Eliquis, which so far is approved for preventing strokes in patients with the heart arrhythmia atrial fibrillation, posted $12 million in sales in the quarter. The partners recently applied for U.S. approval to also sell it for preventing dangerous blood clots in large veins after knee or hip replacement surgery.

Also during the second quarter, Bristol-Myers and partner AstraZeneca PLC applied to the Food and Drug Administration for approval of two drugs. One, called metreleptin, is for treating metabolic disorders linked to a very rare inherited disease.

The other is a second try at getting approval for their new Type 2 diabetes drug, Forxiga, which FDA rejected in January 2012. The agency said then that it needed more data to assess the drug's benefits and risks, and Bristol said it's added data from several new studies.

"In the second quarter, the strength in the performance of some of our key products, the important data we presented across our portfolio and the key regulatory filings we made in the U.S. strengthen our confidence as we build a solid foundation for future growth," CEO Lamberto Andreotti said in a statement.

Meanwhile, Bristol-Myers benefited from the rare treat of a zero tax rate. That was because special charges it took for its business in some countries with high tax rates offset its income taxes elsewhere.

The company said it now expects 2013 earnings per share of $1.41 to $1.49, down sharply from its prior forecast of $1.54 to $1.64. Analysts expect $1.80 per share, on average.

In morning trading, Bristol-Myers shares fell 21 cents to $44.38.

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Follow Linda A. Johnson at http://twitter.com/LindaJ_onPharma.