It's been an encouraging first year as an independent company for AbbVie (NYSE:ABBV) (since its split from Abbott Laboratories (NYSE:ABT)), with full-year results highlighting a positive 2013 and providing an update on what could be an upbeat 2014, too.
Indeed, shares reacted positively to the release and posted gains of more than 3% following the update. As with many health-care stocks, AbbVie hasn't escaped the decline in the wider market, although its shares have picked up in the past few trading sessions to hit $48.90 and deliver gains of 35% over the past year.
In terms of figures for the year, AbbVie reported full-year adjusted earnings per share of $3.14, with fourth-quarter revenue being $5.1 billion. Although revenue numbers were down 1.8% versus the prior quarter, when unfavorable exchange-rate fluctuations are excluded and sales from the lipid franchise are also excluded (because of the loss of exclusivity), sales increased by just under 8% in the quarter.
These figures were boosted by the continued strength of HUMIRA, with global HUMIRA sales increasing by 13.4% and U.S. HUMIRA sales growing by just over 18%. Meanwhile, research and development spend continues to be generous at 15.6% of sales in the fourth quarter, with AbbVie continuing to invest in its mid- and late-stage pipeline assets as well as the continued pursuit of additional HUMIRA indications.
On this topic, AbbVie announced the completion of its phase 3 hepatitis C virus, or HCV, studies on the day of its results release. The news was positive, with patients enrolled in the trials sustaining relatively high responses to treatments.
In addition, AbbVie also announced positive top-line phase 3 HCV results from the SAPPHIRE-I and SAPPHIRE-II studies during the quarter, which examined AbbVie's HCV regimen in naive and treatment-experienced patients. Results showed that treatment with AbbVie's 3-DAA therapy plus ribavirin produced high SVR rates of 96%, while the regimen was also well tolerated by patients receiving the combination.
Furthermore, AbbVie announced during the quarter the initiation of two further phase 3 trials, which highlights the potential the company has in its mid and late-stage pipeline assets, again confirming why research and development spend is crucial to the continued success of the company.
As mentioned, the loss of exclusivity on the lipid franchise swung fourth-quarter revenues from a gain to a loss. However, loss of exclusivity has hit many of AbbVie's sector peers much harder, with Eli Lilly (NYSE:LLY), for instance, reporting a 12% decline in fourth-quarter net profit.
This was largely due to Eli Lilly's loss of patent protection for its biggest product, the antidepressant Cymbalta. Furthermore, Eli Lilly is set to lose patent protection on Evista (a bone-building drug) as soon as next month, although (as with AbbVie) it has a relatively strong pipeline and submitted four new drugs for regulatory review in the most recent quarter.
In addition, sector peer Merck (NYSE:MRK) saw EPS fall by more than 13% in the fourth quarter of 2013 as the challenge from generic drugs was maintained. For example, sales of Singulair fell by 38% when compared with the fourth quarter of 2012. However, Merck continues to invest in its pipeline and is anticipating regulatory actions for multiple drugs in 2014, including Noxafil IV and Vintafolide in the European Union.
So, while generic competition did swing AbbVie's fourth-quarter revenue from a gain to a loss, it didn't make as severe an impact as it did with sector peers Merck and Eli Lilly. Indeed, the first full year as an independent company has been a relatively successful one for AbbVie, and with multiple mid- to late-stage assets in its pipeline, 2014 could prove to be a second successful year since its split from Abbott Laboratories.