abbvie inc (ABBV) Key Developments
AbbVie Inc. Presents First Detailed Results from Pivotal Phase III Study
Mar 3 14
The first detailed results from AbbVie's pivotal phase III study, PEARL-III, were presented as part of the 21st Conference on Retroviruses and Opportunistic Infections (CROI) press conference and will also be presented as a late-breaker at the conference on March 4. PEARL-III evaluated the efficacy and safety of 12 weeks of treatment with AbbVie's investigational therapy with or without ribavirin (RBV) in non-cirrhotic, adult patients with chronic genotype 1b (GT1b) hepatitis C virus (HCV) infection who were new to treatment. The PEARL-III study met its primary and secondary endpoints. In the 419-patient study, sustained virologic response rates 12 weeks post-treatment (SVR(12)) of 99.5 and 99.0% were achieved with the AbbVie regimen with and without RBV, respectively. There were no study drug discontinuations due to adverse events. PEARL-III enrolled patients across different demographics and characteristics. Response rates in patients with certain characteristics (male gender, Black race and IL28B non-CC genotypes) were examined, as these patient populations have historically been associated with having a decreased response to treatment. High response rates were observed across all patients in the study, including those with these characteristics. PEARL-III is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's regimen with and without RBV in non-cirrhotic, GT1b HCV-infected, treatment-naive adult patients. The study population consisted of 419 GT1b treatment-naive patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without RBV for 12 weeks, and 210 patients randomized to the regimen with RBV for 12 weeks. Following 12 weeks of treatment, 99.0% receiving the regimen without RBV (n=207/209) and 99.5% receiving the regimen with RBV (n=209/210) achieved SVR(12). Patients in the treatment arm without RBV received placebo in substitution for RBV. Patients with different demographics and characteristics were enrolled in the study, including gender, race (Black vs. non-Black), Hispanic/Latino ethnicity, age, geographic region, body mass index (BMI), liver fibrosis stage, IL28B genotype and viral load. Across treatment arms in PEARL-III, there were no documented relapses within 12 weeks post-treatment. No on-treatment virologic failures occurred in the treatment arm without RBV and a single virologic failure occurred in the treatment arm with RBV. While all patients in the study completed therapy, two patients in the arm without RBV were lost to follow-up and therefore were considered treatment failures. The most commonly reported adverse events (>10% for either arm) were headache, fatigue, pruritus, nausea and asthenia, with pruritus and nausea occurring at a statistically higher rate in the treatment arm with RBV compared to the arm without RBV. Anemia occurred more commonly among patients in the RBV-containing arm with clinically significant anemia requiring RBV dose reductions occurring in 9% of these patients.
AbbVie Inc. Declares Quarterly Cash Dividend, Payable on May 15, 2014
Feb 20 14
The board of directors of AbbVie Inc. increased the company's quarterly cash dividend by 5% from $0.40 per share to $0.42 per share. The cash dividend is payable on May 15, 2014 to stockholders of record at the close of business on April 15, 2014.
AbbVie Inc. Presents at 8th Annual BIO Europe Spring 2014, Mar-10-2014 01:30 PM
Feb 9 14
AbbVie Inc. Presents at 8th Annual BIO Europe Spring 2014, Mar-10-2014 01:30 PM. Venue: OVAL Lingotto, Turin, Italy. Speakers: Dieter Ziegler, Director, Ventures and Early Stage Collaborations.
AbbVie Inc. Expands Manufacturing Presence with $320 Million Investment in Singapore
Feb 6 14
AbbVie Inc. announced a $320 million [approximately SGD 400 million] investment to establish operations in Singapore for small molecule and biologics active drug substance manufacturing. The completed facility will provide manufacturing capacity for emerging compounds within the company's oncology and immunology pipeline to serve markets globally. The investment will establish the first manufacturing presence in Asia by the company. The investment is expected to result in additional headcount of more than 250 new employees. The company anticipates the new facility will be fully operational by 2019.
AbbVie Inc. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2013; Provides Earnings Guidance for the First Quarter and Full Year 2014
Jan 31 14
AbbVie Inc. reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2013. For the quarter, the company reported net sales of $5,111 million compared to $5,206 million a year ago. Operating earnings were $1,535 million compared to $1,821 million a year ago. Earnings before income taxes were $1,439 million compared to $1,713 million a year ago. Net earnings were $1,128 million or $0.70 per diluted share compared to $1,540 million or $0.98 per diluted share a year ago. Pre-tax adjusted earnings were $1,702 million. Adjusted earnings after tax were $1,325 million or $0.82 per diluted share.
For the year, the company reported net sales of $18,790 million compared to $18,380 million a year ago. Operating earnings were $5,664 million compared to $5,817 million a year ago. Earnings before income taxes were $5,332 million compared to $5,725 million a year ago. Net earnings were $4,128 million or $2.56 per diluted share compared to $5,275 million or $3.35 per diluted share a year ago. Pre-tax adjusted earnings were $6,515 million. Adjusted earnings after tax were $5,066 million or $3.14 per diluted share.
The company provided earnings guidance for the first quarter and full year 2014. The company expects adjusted earnings per share in the first quarter of $0.67 to $0.69. This excludes roughly $0.08 of specified items and noncash amortization, resulting in a first quarter EPS in the range of $0.59 to $0.61 on a GAAP basis. First quarter outlook reflects a flat top line, including roughly 1% negative exchange. The company expects the gross margin ratio somewhat in line with its full year guidance.
The company expects 2014 revenue of approximately $19 billion, excluding any potential revenue from the expected 2014 U.S. launch of HCV therapy. AbbVie is issuing diluted earnings-per-share guidance for the full-year 2014 of $3.00 to $3.10 on an adjusted basis, or $2.63 to $2.73 on a GAAP basis. The company's 2014 adjusted diluted earnings-per-share guidance excludes $0.37 per share of intangible asset amortization expense and other specified items primarily associated with certain separation-related costs and ongoing restructuring activities. The company continues to expect an adjusted tax rate of approximately 22% in 2014.