Drugmaker Bristol-Myers Squibb Co., which will report second-quarter results before the stock market opens Thursday, likely will focus on three recently approved drugs and their launches, plus issues with a key experimental diabetes drug.
WHAT TO WATCH FOR: Bristol-Myers, which sells blockbuster blood thinner Plavix and drugs for diabetes and HIV, will talk about its new blood thinner, skin cancer treatment and transplant rejection drug.
_Nulojix was approved June 16 in the U.S. for patients who have had a kidney transplant, so the launch is just beginning. Food and Drug Administration approval of the injected biologic drug had been delayed since late last year while the company fixed deficiencies at the Puerto Rico factory where it will be packaged. The drug is the first in a new class of transplant drugs that control effects of immune cells called T-cells.
_Yervoy, for treating advanced melanoma, was approved two weeks ago for sales in Europe and in late March for U.S. sales. Known chemically as ipilimumab, it's praised by researchers as the first drug shown to prolong lives of patients with the sometimes-deadly skin cancer.
_Eliquis, a new blood thinner Bristol has been developing with Pfizer Inc., got approved for use in the 27 European Union countries on May 20. Pfizer and Bristol-Myers plan to apply later this year for FDA approval.
Eliquis, known chemically as apixaban, has been touted as a possible blockbuster, able to prevent blood clots without the bleeding side effects of older drugs such as warfarin. However, last year the companies had to halt a 10,000-patient study in heart disease patients after an unexpected number of bleeding side effects. Detailed results from an even bigger international study are to be presented at a medical conference next month.
Bristol executives also will discuss their next steps after a panel of FDA advisers voted against recommending approval of dapagliflozin, a diabetes drug that uses a new method to reduce blood sugar, after a study found higher rates of bladder and breast cancer than patients taking a dummy pill. The global diabetes market is huge and an important area for Bristol-Myers, which is seeking approval in China for its two-year-old Onglyza.
Credit Suisse analyst Catharine Arnold is looking for updates on sales of some existing products, including Onglyza, a heavily touted Type 2 diabetes drug whose sales have been disappointing, and Kombiglyze, which combines Onglyza with a standard generic diabetes drug, metformin. Rival Merck & Co.'s Januvia is in the same DPP-4 inhibitor class of diabetes drugs but hit the market first and has bigger sales.
Bristol-Myers executives also will discuss last week's $475 million deal to buy privately held drug developer Amira Pharmaceuticals to acquire its key research programs, which could produce drugs in areas with inadequate treatment. Those include a drug ready for effectiveness testing in people that could treat both the fatal lung disease pulmonary fibrosis and scleroderma, a chronic autoimmune disease that damages connective tissue and some internal organs. Amira also has research programs that could lead to treatments for nerve pain and for cancerous tumors that have spread.
Bristol-Myers may discuss its financial forecast for the year and give an update on layoffs and other cost-cutting efforts.
WHY IT MATTERS: The company faces the loss of billions of dollars a year when its top-selling product, blood thinner Plavix, gets generic competition next May. It could lose billions more in revenue over the next four years as patent exclusivity also ends for bipolar disorder treatment Abilify, HIV treatment Sustiva and blood pressure drug Avapro. With Plavix, the four drugs' combined annual sales total nearly $12 billion out of Bristol's roughly $20 billion total.
The three new drugs, and others in the pipeline, are crucial to replacing revenue from those blockbusters. Bristol has been remaking itself into a biopharmaceutical company, specializing in pricey biologic drugs "manufactured" in living cells, unlike rivals that have been diversifying into consumer, animal and generic drugs to generate stable revenue as they deal with their own generic competition.
Bristol-Myers stopped one of two late-stage studies of its biologic drug for non-small cell lung cancer, necitumumab, in February after signs of increased risk of dangerous blood clots. The company has not given an update since then, but analysts probably will ask about it. The other study is continuing.
WHAT'S EXPECTED: Analysts surveyed by FactSet, on average, expect earnings per share of 55 cents and revenue of $5.05 billion.
LAST YEAR'S QUARTER: A year ago, Bristol-Myers reported net income of $927 million, or 53 cents per share, down 6 percent because it had spun off its former nutrition business. But revenue was up 2 percent, at $4.77 billion.