Generic competition and foreign exchange led to a dip in AbbVie fourth-quarter sales but its anti-inflammatory blockbuster Humira continues to soar.
Net income was $968 million, down 27% to $1.13 billion, while revenues slipped 1.8% to $5.11 billion. The majority of that came from Humira (adalimumab), which is approved for indications covering rheumatoid arthritis, Crohn’s disease and psoriasis; the world’s best-selling drug contributed $3.04 billion, a rise of 13.4% and for the full year, sales hit $10.66 billion (+15%).
As for the company’s lipids franchise, TriCor (fenofibrate) and TriLipix (fenofibric acid) saw sales sink 85.4% to $29 million, hit by the loss of patent protection. Niaspan (niacin) brought in just $31 million, collapsing 88.9%, while the respiratory treatment Synagis (palivizumab), the AstraZeneca drug sold by AbbVie outside the USA, fell 6.4% to $314 million.
Revenues from the HIV drug Kaletra (lopinavir/ritonavir) decreased 8.6% to $228 million, while sales of the prostate cancer drug Lupron (leuprolide) slipped 1.0% to $209 million. The hypothyroid medication Synthroid (levothyroxine) climbed 12.8% to $189 million, and AbbVie’s AndroGel testosterone replacement therapy fell 20.9% to $289 million.
Chief executive Richard Gonzalez said management is pleased with the performance of AbbVie (the drugs business spun out of Abbott Laboratories) “in our first full year as an independent biopharmaceutical company”. He added that “we achieved all of the objectives we set forth for 2013, exceeded our original earnings guidance, and established a solid foundation for the future”.
Mr Gonzalez went on to say that “we intend to build on this momentum in 2014 as we invest in our key products, advance our pipeline, and prepare for significant product launches that will drive growth in 2015 and beyond”.
Hep C combo impresses again
AbbVie is hoping much of that growth will come from its all-oral, interferon-free regimen for hepatitis C. The firm has presented positive results from four final Phase III studies which, like two previous trials, reveal sustained viral response rates (viral cure) well above the 90% mark.
The regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily. In May 2013, AbbVie’s regimen with and without ribavirin for HCV genotype 1 was designated as a breakthrough therapy by the US Food and Drug Administration and the company impressed analysts by saying it is on track to begin regulatory submissions “early in the second quarter”.
