Another quarter for AbbVie (NYSE:ABBV), another blow-out. The company announced strong third-quarter results last Friday. AbbVie's storyline behind those earnings, though, is probably more important than the numbers themselves. Here are five things the company's management wants investors to know (quotes courtesy of our friends at Thomson Reuters StreetEvents).
1. What has AbbVie done for you lately?
Within seconds of speaking at the company's third-quarter conference call, AbbVie chairman and CEO Rick Gonzalez played up what the company has accomplished in just 22 months of existence. And those accomplishments are pretty impressive.
Gonzalez noted that AbbVie has "delivered a total shareholder return of more than 90%, representing $40 billion of shareholder value creation." He wasn't exaggerating. Anyone who questioned the wisdom of Abbott Laboratories' (NYSE:ABT) decision to spin off the new company a couple of years ago shouldn't be skeptical now.
Both companies have performed well, but AbbVie's performance has been simply astonishing. The stock's price soared 80% since the beginning of 2013. AbbVie has also consistently paid out a solid dividend, with a yield at or above 3% during much of the past two years.
2. Humira's momentum isn't fading
AbbVie's top-selling drug, Humira, continues to rack up huge sales. During the third quarter, Humira generated revenue of $3.255 billion, a year-over-year jump of almost 18%. The even better news, according to AbbVie's management team, is that the momentum shows no signs of slowing down.
Rick Gonzalez says that "Humira's broad label and new indications are a competitive advantage." He's right -- and that competitive advantage could get a boost. AbbVie announced great results in October from a late-stage study of Humira in treating moderate-to-severe hidradenitis suppurativa, or HS. HS is a chronic skin disease that affects around 1% of adults globally. The condition currently has no approved treatment options.
What about the threat of biosimilars for Humira in the years ahead? Gonzalez says that "obviously that is something we have looked at" and that AbbVie has "had now a number of years to put a strategy in place" to deal with the threat. He expressed confidence that the company's strategy will be successful.
3. Ready for hep-C
AbbVie's highly anticipated interferon-free hepatitis-C virus therapy is "on the cusp of approval," according to Gonzalez. The company stated last month that it doesn't think an FDA advisory panel will be needed as a prerequisite for ultimate approval. Gonzalez reiterated that assumption in his earnings call comments.
He said that the company is ready to launch the hep-C combo in the U.S. by the end of this year pending approval. Gonzalez also indicated confidence that AbbVie will receive European regulatory approval in early 2015. He noted that "we've built the appropriate infrastructure and are fully prepared for our launch."
There are some questions about how effectively AbbVie's hep-C regimen will be able to compete against Gilead Sciences' (NASDAQ:GILD) Sovaldi and Harvoni, which have had spectacular success thus far. Rick Gonzalez's response is that "we still don't believe that minor differences in pill count or shorter duration of therapy in certain patients will significantly change the competitive dynamics in this marketplace." He said, "We feel very good about our ability to compete in this market and create meaningful share for our product."
4. Pipeline is promising
It's not all about Humira and hep-C. AbbVie also boasts several other promising drugs in its pipeline. The company counts over 40 clinical development programs in progress, with 12 drugs either in regulatory review or in late-stage clinical studies.
Gonzalez highlighted several of these drugs in his comments to investors. Veliparib stood out as one of the cancer drugs that AbbVie is excited about. AbbVie initiated four late-stage studies of the drug in 2014, including trials targeting breast cancer and non-small cell lung cancer.
He also gave a special shout out to multiple sclerosis drug daclizumab. Gonzalez noted that although MS has seen several advances, daclizumab "has the potential to be an important therapy in this large and growing market." AbbVie expects to complete regulatory filings in the first half of 2015.
5. More good news on the way
Last, but certainly not least, AbbVie's management projected a rosy outlook for the future. The company bumped up its full-year 2014 earnings guidance. Rick Gonzalez said, "We have a high level of confidence that we can continue to drive strong growth over the long term."
So far, there's no reason to question that confidence. As Gonzalez pointed out, AbbVie has delivered superior returns for investors. Humira's sales keep chugging along. The pipeline is strong, particularly with the expected approval of the company's hep-C therapy.
AbbVie's stock has climbed over 20% so far in 2014. If the company's management is right, that success should spill over into next year also.