We might be in the middle of the first quarter, but AbbVie Inc. (ABBV 1.15%) has already delivered enough good news for a whole year. It's been getting hard to pick a favorite indicator, but raising earnings expectations for the year 14% higher was a big one. With operations firing on all cylinders, it's no wonder the big pharma stock has already risen around 23% in 2018.
Despite the recent run-up, there are a few catalysts coming up that could help the stock continue climbing throughout 2018 and beyond. Here's what to look out for.
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1. Upadacitinib: $6.5 billion by 2025?
Rheumatoid arthritis, Crohn's disease, and eczema affect millions, but available therapies aren't a viable option for many of these patients. AbbVie thinks its late-stage candidate upadacitinib could be the most popular member of a new class of drugs aiming to treat these diseases. Humira, the company's flagship injection aimed at these patients, produced $18.4 billion in sales last year. At 65% of total revenue, replacing its eventual losses to biosimilar competition is a top priority
Last summer, AbbVie reported results from a pivotal trial with upadacitinib and patients that didn't respond to previous treatment with three separate types of conventional therapies available today. Across all three trials, upadacitinib wiped the floor with the placebo control groups. In fact, patients taking just 15 mg of the experimental drug daily achieved clinical remission at a rate three to four times higher than those given a placebo.
AbbVie expects to submit a rheumatoid arthritis application package for upadacitinib in the second half of the year. That's too late to expect an approval announcement in 2018, but results from ongoing pivotal trials with upadacitinib as a treatment for Crohn's disease and eczema could lift the stock this year. By eventually expanding the candidate's addressable patient population to include these indications, AbbVie thinks upadacitinib could add up to $6.5 billion in annual sales by 2025.
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2. Risankizumab: Potential psoriasis blockbuster
Upadacitinib isn't the only anti-inflammatory candidate with blockbuster potential in AbbVie's late-stage pipeline. Risankizumab is an experimental injection that thumped Johnson & Johnson's (JNJ -0.10%) blockbuster psoriasis therapy Stelara in a head-to-head study. In a pair of trials, 58% and 60% of patients treated with AbbVie's candidate achieved clear skin, versus just 21% and 30% of patients treated with Stelara.
With results like these, psoriasis applications for risankizumab should be a slam dunk. AbbVie has submissions planned for the first half this year, which means there's a slight chance the FDA could issue an approval decision before the end of the year.
Last year, Johnson & Johnson recorded $4.0 billion in worldwide Stelara sales. The psoriasis space is getting crowded, but AbbVie thinks risankizumab can capture around $5 billion worth of a global market that's expected to reach $21.4 billion annually by 2022.
3. Elagolix: Addressing big unmet needs
Four out of five women develop abnormal pelvic growths called uterine fibroids by their 50th birthday. They're generally asymptomatic, but around 25% of women with these growths experience debilitating symptoms that include painful periods and bleeding at times other than menstruation.
During a pivotal study, 68.5% of patients treated with AbbVie's Elagolix achieved a clinical response, versus just 8.7% in the placebo group. Those results are good enough to take to the FDA, which is already reviewing an Elagolix application for the treatment of another chronic disorder with a lot of underserved patients -- endometriosis.
AbbVie expects the FDA to issue an endometriosis approval decision in the second quarter. While a thumbs-up would help the stock tick a bit higher, it's widely expected. The drug's future popularity, on the other hand, is anybody's guess. Peak annual sales estimates for Elagolix in this indication hover around $1.5 billion. That's nothing to sneeze at, but this disease affects about 1 in 10 women of reproductive age. If a slightly higher-than-expected percentage of addressable patients takes up the treatment, it could go much higher.
Putting it together
Humira still contributes around two-thirds of AbbVie's total revenue, but Amgen has agreed not to launch its biosimilar version of the megablockbuster until 2023. Replacing Humira revenue once it finally starts to slide won't be easy, but there's a chance these three candidates, and perhaps Rova-T, could be strong enough pallbearers to lift Humira's casket when the time comes.
We can't be sure these late-stage candidates will throw off news that moves the stock higher this year, but the odds that AbbVie's impressive earnings will fall off a cliff several years from now are definitely getting a lot slimmer.
