Earnings Preview:
J&J to cite deals, drugs OK'd

[October 15, 2011]  TRENTON, N.J. (AP) -- Health care giant Johnson & Johnson likely will discuss its pipeline, recent drug approvals and several important deals when it reports its third-quarter results before the stock market opens Tuesday.

WHAT TO WATCH FOR: Executives will tout progress addressing problems behind an embarrassing string of product recalls that's hurt J&J's revenue and image, and their plans to get some of J&J's many recalled consumer health products back on the market. Last month, J&J said it resumed shipping Tylenol Cold & Flu Severe caplets, just ahead of cold season.

Since September 2009, the company has issued more than 25 recalls, including a few prescription medicines, contact lenses and defective hip replacements, for reasons ranging from improper potency to glass or metal shards in liquid medicines. The latest recall, on Sept. 23, affected 200,000 syringes of anemia drug Eprex sold outside the U.S., because of inconsistent potency.

The company may give updates on several pending deals.

Its biggest acquisition ever -- $21.3 billion to buy U.S.-Swiss medical device maker Synthes Inc. and boost its position in the growing market for orthopedic surgery products -- is still expected to close in the first half of 2012.

In late September, J&J paid $175 million to buy out Merck & Co.'s half interest in their 22-year-old joint venture, Johnson & Johnson-Merck Consumer Pharmaceuticals Co., which sells over-the-counter versions of former prescription drugs, including stomach medicines Pepcid, Mylanta and Mylicon. J&J will rename the business McNeil Consumer Pharmaceuticals Co.

A $345 million agreement to sell dermatology businesses that make products including wrinkle and acne cream Retin-A to Canada's Valeant Pharmaceuticals International Inc. is still expected to close by year-end, although the Federal Trade Commission has asked for more information. And J&J's Ethicon Endo-Surgery business agreed in late September to buy privately held SterilMed Inc. It repairs and sterilizes used medical devices such as those made by J&J's biggest division, medical devices and diagnostics.

During the third quarter, the maker of baby shampoo, biologic medicines and birth control pills saw several drugs win new approvals, including extended-release Nucynta, a narcotic pill for moderate-to-severe chronic pain. One product was rejected.

Last month, a panel of advisers to the Food and Drug Administration recommended the agency approve use of anticlotting drug Xarelto for preventing stroke in patients with a common irregular heart rhythm called atrial fibrillation. The FDA is expected to make a decision in the first week of November.

The drug was approved here in July for a much smaller patient group, those getting knee and hip replacement surgery. J&J and partner Bayer Healthcare of Germany plan by year-end to apply in the U.S. and Europe for approval to sell it for patients with acute coronary syndrome, in which blood supply to the heart is blocked, causing chest pain or a heart attack.

Regulators in the European Union in September approved sales of J&J's Zytiga, a new pill for treating advanced prostate cancer after chemotherapy. It was approved in the U.S. in April, so initial sales here likely will be discussed.

Also in September, the EU approved sales of Incivo, one of two new drugs that greatly improve cure rates for tough-to-treat hepatitis C. J&J has rights to sell it in most countries outside North America. Two partners have the rights in North America, where it selling under the name Incivek, and some Asian countries.

J&J's blockbuster immune disorder drug Remicade, already approved for 15 uses, last month won another approval, for treating children with ulcerative colitis. But in July, U.S. regulators rejected a new use for successor drug Simponi, for slowing structural damage in rheumatoid arthritis patients. The company is to meet with FDA officials in November to discuss how to proceed.

Analysts may ask about a tentative settlement reached in August to settle a criminal charge in a multiyear government investigation over marketing psychiatric drug Risperdal for unapproved uses. A company spokeswoman could not say when the settlement will be finalized or disclose the financial penalty. Meanwhile, cases involving improper marketing or overcharging state governments continue in 11 states, but a case was dismissed in West Virginia.

Last week, J&J agreed to pay $85 million to the Department of Justice to resolve allegations it improperly marketed heart failure drug Natrecor for chronic use, instead of just for patients with acute heart failure.

WHY IT MATTERS: WBB Securities analyst Steve Brozak says J&J executives need to reassure investors, particularly large institutional fund investors, that there's a reason "to own the stock other than just the dividend" -- a fairly generous 57 cents per quarter.

Brozak says J&J has to convince investors the recalls are behind the company and that it has a strong pipeline of experimental drugs that are affordable. The New Brunswick, N.J., company does have flexibility because of its strong free cash flow, but needs to invest far more in research and acquisitions, he notes.

WHAT'S EXPECTED: Analysts polled by FactSet, on average, expect earnings per share of $1.21 and sales of $16.02 billion.

LAST YEAR'S QUARTER: Net income was up slightly at $3.42 billion, or $1.23 per share. Revenue totaled $14.98 billion, down almost 1 percent and $200 million below what analysts expected.

[Associated Press; By LINDA A. JOHNSON]

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