Earnings Preview: J&J 1Q to focus on newest drugs

TRENTON, N.J. (AP) -- Johnson & Johnson will highlight the recent approval of its first drug in the huge diabetes market, plus progress toward getting two other drugs approved, when it reports first-quarter results before the stock market opens Tuesday.

WHAT TO WATCH FOR: The world's biggest maker of health care products will focus on the March 29 U.S. approval of Invokana, known chemically as canagliflozin. The daily pill is the first drug in a new class of Type 2 diabetes medicines that work by increasing how much sugar is excreted via urine.

J&J's first entry in the multibillion-dollar medicine market fueled by the global diabetes epidemic, Invokana will complement its OneTouch and Vibe lines of all manner of diabetes devices. Executives should discuss plans for launching Invokana, including having sales reps for those diabetes devices promote it. It's awaiting approval in some other countries.

Chief Financial Officer Dominic Caruso will update J&J's 2013 profit forecast. He will note a charge of about 4 cents per share due to Venezuela's currency devaluation and likely discuss exchange rate effects.

J&J will note prostate cancer drug Zytiga got European Union approval in January for use earlier in treatment — before chemotherapy.

J&J, based in New Brunswick, N.J., just applied for Food and Drug Administration approval of simprevir, its second drug for hepatitis C. That's another disease with a fast-growing market, as baby boomers infected decades ago finally get diagnosed with the silent liver-destroying disorder.

This week, the FDA granted a third breakthrough therapy designation for a cancer drug still in testing, ibrutinib. That's meant to speed up late-phase testing and review of the drug. J&J plans this year to seek approval for the drug as a treatment for mantle cell lymphoma.

Those positives are offset by a surge of litigation over allegedly faulty products, plus the company's continuing struggle to end an eye-popping streak of about three dozen product recalls. Most were nonprescription medicines, including Tylenol and Motrin. Reasons range from nauseating packaging smells to tiny glass and metal shards in liquid medicines. Some products are still off store shelves after three years, reducing revenue. The company is rebuilding one factory from the ground up and making other manufacturing improvements under an agreement with the FDA, hiking the tab.

The No More Tears shampoo maker is facing thousands of lawsuits over mesh implants to lift sagging pelvic organs that have caused pain, infection and other complications; painful, recalled artificial hips and a schizophrenia drug, Risperdal, blamed for triggering diabetes. The Justice Department and numerous states have sued J&J over improper marketing of Risperdal, for allegedly downplaying side effects and paying bribes to get nursing homes to put patients on the drug. It turned out to hasten death in elderly people with dementia.

WHY IT MATTERS: J&J has put the worst of its hits from generic competition behind it, is enjoying rising sales from the blood thinner Xarelto and just got another likely blockbuster approved, Invokana. But the product recalls continue, although they're rarer these days.

CEO Alex Gorsky, who took over last April, seems to be enjoying a honeymoon with analysts and investors, who are watching to see how he'll make good on his priorities, particularly fixing the consumer health business.

In December, he brought in a highly regarded Bayer AG exec, Sandra Peterson, to run the division, making her the first outsider ever to join the executive committee that manages J&J.

J&J's stock price had been virtually flat for the decade through last June, limiting its appeal mainly to investors seeking a safe harbor and a strong dividend. But since last June, shares have run up from $62 to just over $82 now. Shares hit an all-time high of $82.95 this month. And suddenly analysts are talking up the stocks of J&J and many big drugmakers.

WHAT'S EXPECTED: Analysts polled by FactSet, on average, expect earnings per share of $1.40 and sales of $17.46 billion.

LAST YEAR'S QUARTER: J&J reported net income of $3.91 billion, or $1.41 per share, on revenue of $16.14 billion.

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