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News Breaks
April 15, 2014
08:56 EDTJNJJohnson & Johnson sees FY net interest expense $400M-$500M
Says early Q1 data shows continued softer utilization trends impacted by the severe winter conditions. Says data shows continued slight declines in the rates of surgical and lab procedures in the U.S., similar to what was seen over the past 12 months. Says strong Q4 utilization in orthopedic procedures softened in Q1 due to some seasonality. Says confident overall about the long-term health of the market as economic conditions continue to recover. Says Japanese yen to be a headwind in 2014, although that negative impact to gross margin will increase throughout the year. Sees FY14 net interest expense $400M-$500M, effective tax rate 19%-20%. Says guidance for 2014 anticipates that the R&D tax credit will be renewed by Congress. Says expects continued pricing pressure in 2014 across many markets, particularly in Europe; says impact of this negative pricing pressure to negatively impact pretax operating margin by approximately 50bps. Says "comfortable" with models reflecting an operational sales increase on a constant currency basis of 5%-6% for the year. Says if currency exchange rates for all of 2014 were to remain where they were as of last week, sales growth rate would decrease by nearly half a percent. Says this would result in sales for 2014 on a constant currency basis of approximately $74.9B-$75.7B. Says that if exchange rates for all of 2014 were to remain where they were as of last week, then our reported EPS excluding special items would be positively impacted by approximately 6c per share due solely to exchange rate fluctuations. Comments made on the Q1 earnings conference call.
News For JNJ From The Last 14 Days
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July 6, 2015
10:02 EDTJNJWi-LAN enters settlement, license agreement with Cordis
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July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.

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