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TAKING THE PULSE: The drug industry's patent cliff likely will remain in focus during the first quarter as Pfizer Inc. (PFE) reports its first full period without market exclusivity for former blockbuster anticholesterol pill Lipitor. Eli Lilly & Co. (LLY) may see another tough quarter since the October loss of patent exclusivity for antipsychotic drug Zyprexa. The period also marks the final quarter with William Weldon at the helm of Johnson & Johnson (JNJ). Weldon, who was chief of the health-care products company for 10 years, is to be succeeded by company veteran Alex Gorsky.
Drug makers have been aiming to rein in costs and find new drugs or additional uses for older ones to replace lost revenue as top sellers face generic competition. Companies are vying to bring treatments to market in anticipated growth areas such as diabetes, hepatitis C and weight loss, as well as taking steps into targeted treatments--sometimes referred to as personalized medicine--as opposed to their traditional focus on blockbuster drugs aimed at large groups of people.
COMPANIES TO WATCH:
Johnson & Johnson (JNJ) -- reports April 17
Wall Street Expectations: Analysts forecast a profit of $1.35 a share on $16.27 billion in revenue, compared with earnings of $1.25 a share, or $1.35 excluding litigation and DePuy hip recall-related charges, on revenue of $16.2 billion a year earlier.
Key Issues: J&J continued to struggle to put a series of costly recalls of over-the-counter medicines and litigation related to its antipsychotic Risperdal behind it. However, the quarter saw new recalls within its Tylenol brand, and The Wall Street Journal reported that federal prosecutors rejected a proposed $1 billion settlement of charges that it promoted Risperdal for unapproved uses. J&J's new chief brings experience in the medical-devices arena, a business the company has been trying to reshape as sales remain under pressure from consumers delaying elective surgeries, as well as pricing pressures from health payers in the U.S. and Europe. Biomet Inc.'s recent offer to acquire the global trauma business of JNJ's DePuy Orthopaedics Inc. is expected to help clear regulatory hurdles for its pending $21.3 billion acquisition of medical-device maker Synthes Inc. (SYST.VX), which is expected to close in the first half of the year.
Eli Lilly & Co. (LLY) -- reports April 25
Wall Street Expectations: Analysts forecast a profit of 78 cents a share on $5.34 billion in revenue, compared with earnings of 95 cents a share, or $1.24 excluding research and development charges related to collaborations and licensing agreements and other items, on revenue of $5.84 billion a year earlier.
Key Issues: Lilly will report its second quarter to include the loss of patent exclusivity for Zyprexa. Lilly, which is relying on its own research labs as opposed to large-scale acquisitions, has continued efforts to rein in costs. Most recently Lilly unveiled plans to freeze base pay for most of its global work force of about 38,000 this year to cope with pressures from expiring patents. Lilly is set to lose patent protection on several more of its largest products over the next five years including antidepressant Cymbalta, and cancer drugs Evista and Alimta. Analysts are expected to be watching for any details about Lilly's experimental Alzheimer's disease drug solanezumab and its diabetes pipeline. Lilly received Food and Drug Administration approval for its diabetes treatment that combines two drugs into a single pill. The drug, Jentadueto, was developed with Boehringer Ingelheim GmbH. The FDA also approved a much-anticipated test developed by Lilly that detects the presence of proteins in the brain that are related to Alzheimer's disease.
Merck & Co. (MRK) -- reports April 27
Wall Street Expectations: Analysts forecast a profit of 97 cents a share on $11.83 billion in revenue, compared with earnings of 34 cents a share, or 92 cents excluding purchase accounting adjustments, arbitration settlement charges and other items, on revenue of $11.58 billion a year earlier.
Key Issues: Merck has been cutting costs, including massive layoffs announced last year, and turning its efforts to bring new drugs to market as the August loss of patent exclusivity for top selling allergy and asthma medication Singulair draws closer. The drug maker has been focusing on areas such as hepatitis C and diabetes. How the company's hepatitis C drug Victrelis fares in the hotly contested market likely will be in focus. While Merck last month predicted currency fluctuations would reduce first-quarter sales by 1% to 2%, investors likely will be more concerned about the outlook for the company's drug pipeline. Merck in February said it expects to seek regulatory approval for five new products this year and in 2013. They include potential treatments for osteoporosis and insomnia and a next-generation vaccine against a cancer-causing virus.
Pfizer Inc. (PFE) -- reports May 1
Wall Street Expectations: Analysts forecast a profit of 56 cents a share on $15.44 billion in revenue, compared with earnings of 28 cents a share, or 60 cents excluding impacts related to its Wyeth acquisition, on revenue of $16.5 billion a year earlier.
Key Issues: While the world's biggest drug maker by sales copes with the loss of Lipitor's market exclusivity, analysts also will be watching for any details related to the expected sale of its infant-nutrition unit and a spinoff or sale of its animal health division as the company aims to focus on its core pharmaceuticals business. Despite efforts to retain as much of the Lipitor market as possible, Pfizer's fourth-quarter profit slumped 50% as global Lipitor sales fell 24%, with U.S. sales down 42%. The company has reported progress on a number of fronts as it aims to improve its pipeline. Pfizer's Prevnar 13 vaccine to prevent pneumonia met safety goals in a Phase 3 study of children and adolescents ages 5 through 17, supporting efforts to expand the treatment's use to more age groups. The FDA also granted a priority review of its tafamidis meglumine treatment for a deadly genetic disease, part of the company's foray into the rare-disease segment. Among setbacks, the FDA delayed a decision on Pfizer and Bristol-Myers Squibb Co.'s (BMY) proposed new anticlotting drug Eliquis by three months to June 28.
(The Thomson Reuters estimates and year-earlier earnings may not be comparable due to one-time items and other adjustments.)
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;