When AbbVie won FDA approval for its next-generation immunology drugs Skyrizi and Rinvoq in 2019, the company had high hopes that the drugs could fill what threatened to be a gaping hole in the top line from the impending patent losses on the $20-billion-a-year Humira. Wall Street skeptics weren’t so sure.
But fast forward to now, and AbbVie seems to be winning over many of those doubters—despite a cloud of safety concerns hanging over Rinvoq.
Combined sales of Skyrizi and Rinvoq came in at $2.3 billion in 2020, and CEO Rick Gonzalez told investors during the fourth-quarter conference call to expect that haul to double this year. AbbVie expects the two products to be pulling in $15 billion in 2025.
Rinvoq, an oral JAK inhibitor, is approved to treat rheumatoid arthritis, and AbbVie is gunning for an approval in several other diseases, including atopic dermatitis, a market dominated by Sanofi and Regeneron’s Dupixent. In a phase 3b head-to-head trial reported in December, Rinvoq outperformed Dupixent on a number of endpoints—including helping 71% of patients report high scores on the Eczema Area and Severity Index (EASI) versus just 61% of Dupixent patients.
But Rinvoq’s label warns of a risk of life-threatening blood clots, and one patient in the phase 3 trial in RA died of a hemorrhagic stroke. And just last week, Pfizer disclosed data from a post-marketing trial of its competing JAK inhibitor, Xeljanz, showing an increased risk of cardiovascular events and cancer compared to TNF inhibitors.
During AbbVie’s conference call, R&D chief Michael Severino, M.D., addressed the Pfizer study, emphasizing that Xeljanz’s risks don’t necessarily extend to the entire JAK class. “We are not aware of any signal of an elevated risk” for heart problems and cancer “with any JAK inhibitor, other than Xeljanz,” he said.
The FDA is currently weighing Rinvoq in psoriatic arthritis, a market that AbbVie also hopes to crack with Skyrizi, its IL-23 blocker currently approved in plaque psoriasis. The company scored a big Skyrizi win last month when it reported that the drug outperformed placebo at improving psoriatic arthritis symptoms in two phase 3 clinical trials.
The hot-shot pair helped make up for a couple of misses during the quarter, including one notable shortfall in AbbVie’s growing oncology portfolio. Sales of Venclexta came in at $365 million, missing the consensus estimate of $372 million.
AbbVie continues to test Venclexta, which is approved to treat some forms of leukemia and lymphoma, in a variety of settings, but results have been mixed. Last year, the drug flunked a confirmatory trial in acute myeloid leukemia (AML), but just a few weeks later, a trial combining the drug with the chemotherapy azacytidine turned out positive results.
AbbVie is expecting several key Venclexta readouts this year, including results from trials combining it with another AbbVie oncology drug, Imbruvica, in second-line mantle cell lymphoma and front-line chronic lymphocytic leukemia (CLL).
During the conference call, Gonzalez admitted that some of Venclexta’s slowdown was due to COVID restrictions. “What we’re seeing clearly is that COVID is having an impact on patient starts in CLL,” he said. Oncology practices are trying to reduce patient traffic, he said, and CLL is a disease “where you can delay therapy for some period of time.”
But COVID didn’t hamper AbbVie’s ability to surpass expectations. All told, the company reported $13.86 billion in sales for the fourth quarter and $2.92 in adjusted earnings per share, beating the consensus estimates of $13.7 billion in sales and EPS of $2.85. For the full year, AbbVie told analysts to expect EPS of $12.32 to $12.52—handily beating the consensus estimate of $12.18. Investors were giddy, sending the company’s shares up more than 3% to nearly $107 in premarket trading.
As for the loss of exclusivity on Humira, that’s looming in 2023. Gonzalez said he’s not worried. “We have a high degree of confidence that we will be able to successfully absorb the Humira [loss-of-exclusivity] impact in 2023, supporting an immediate return to total sales growth in 2024 and produce compelling high single-digit compounded annual total sales growth in 2025,” he said.