Bristol-Myers faces lung-cancer setback - MarketWatch

Bristol-Myers Squibb Co. said its fourth-quarter revenue rose on sales of key drugs, and the company expects further growth this year as it works to complete the planned $74 billion acquisition of rival cancer drugmaker Celgene Corp.

New York-based Bristol also said Thursday it suffered another setback entering the market to treat newly diagnosed lung-cancer patients, withdrawing its application for U.S. approval of a combination of its Opdivo and Yervoy therapies because more data was needed.

The company said it swung to a fourth-quarter profit of $1.2 billion, or 73 cents a share, from a year-earlier loss of $2.3 billion, or $1.42 cents a share. Revenue climbed 10% to $6 billion.

Analysts surveyed by FactSet expected a profit of 82 cents a share on $6 billion in revenue.

The quarter's results were driven by Bristol's top-selling products, including Opdivo, whose sales rose 33% from a year earlier, and blood thinner Eliquis, which logged a 25% jump in sales.

Bristol expects this year to earn $3.75 to $3.85 a share and for sales to increase in the mid-single-digits. For 2018, the company reported earnings of $3.03 a share and said sales grew 9% to $22.6 billion.

Bristol said the forecast doesn't take into account the impact of its agreement to buy Celgene, which the companies announced earlier this month.

The deal would bring together two leading but troubled cancer-drug sellers. Celgene leads the market for multiple-myeloma treatments, but its top-selling drug, Revlimid, is expected to face competition from generics in 2022.

Bristol pioneered the development of treatments known as immunotherapies, which unleash the patient's own immune system to fight cancer and have become widely used in the treatment of lung and skin tumors.

But Bristol has seen other drug makers, notably Merck & Co., catch up scientifically and commercially.

Merck's Keytruda immunotherapy scored a major advantage when it received U.S. approval for newly diagnosed lung-cancer patients, while Bristol's Opdivo immunotherapy failed a trial to show its effectiveness in the patients.

Since then, Bristol has been trying to catch up in newly diagnosed lung cancer patients, including conducting a study to see whether a combination of Opdivo with the company's Yervoy immunotherapy benefited the patients.

Bristol focused on lung-cancer patients whose tumors have a high number of genetic mutations, known as tumor mutational burden, or TMB.

Yet in October, the company said the FDA had moved back a deadline to rule on approving the combination in the high-TMB patients.

On Thursday, the company said it was withdrawing the application altogether because more data are needed related to TMB and the overall survival of patients. The data won't be available in time under the FDA's timetable for deciding whether to approve the drug combination, the company said. The trial is still ongoing.

Bristol shares, down about 4% so far in 2018, closed Wednesday at $49.96.

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