After the Phase II failure of its lead asset from Cerevel, AbbVie is resetting expectations and narrowing the clinical program to an adjunct approach—for now.
AbbVie is shrinking expectations for schizophrenia asset emraclidine for the time being after it failed a pair of Phase II trials late last year. The drug will now be advanced as an adjunct treatment in combination with existing therapies for the neuropsychiatric disorder.
“We still see opportunity in adjunctive schizophrenia as well as neurodegenerative psychosis, and we haven’t completely given up on the monotherapy opportunity either, but that’s a more heavily risk adjusted opportunity now,” CEO Robert Michael said on a fourth quarter earnings call on Friday morning.
Emraclidine failed on the primary endpoint of improvement in positive and negative symptoms of schizophrenia as compared to placebo at week six in the mid-stage EMPOWER trials. AbbVie promised to analyze the results further and figure out a path forward.
AbbVie was forced to take a $3.5 billion impairment charge over the asset, which came from the $8.7 billion acquisition of Cerevel Therapeutics in December 2023. Speaking to this charge, Michael highlighted Parkinson’s disease therapy tavapadon, another Cerevel asset that hit the primary endpoint of a Phase III trial a few weeks after the emraclidine failure. AbbVie is bullish on this asset but unfortunately could not include it as value to absorb some of the blow from the impairment charge due to accounting rules, Michael explained on Friday’s call.
At the J.P. Morgan Healthcare Conference earlier this month, AbbVie hinted at the next steps for emracldine. Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, said then that a review of the data showed the placebo response was site-specific, meaning different sites administering the trials saw varying placebo responses that brought the efficacy signal into question.
On the earnings call, Thakkar laid out the path ahead. “When assessing sites beyond those with high placebo response, a clear efficacy signal was observed, albeit more modest than reported in Phase Ib, therefore we see a path forward as an adjunct to atypicals in schizophrenia and as a monotherapy in psychosis related to Alzheimer’s and Parkinson’s.”
In those two disorders, Thakkar said there is a high unmet need for safe and tolerable options, even if they provide just a “modest benefit.”
The company will explore higher doses of emraclidine, given it showed a clean safety and tolerability profile in the Phase II schizophrenia trial. AbbVie will conduct a multiple ascending dose study this year with data available in the early part of 2026, the R&D chief explained. If these high doses show a better response, Thakkar said they could pursue emraclidine as a monotherapy in schizophrenia again, but will at least likely pursue a Phase II study in adjunctive schizophrenia.
Meanwhile, the Alzheimer’s and Parkinson’s programs are moving forward, with dose ranging occurring now. AbbVie plans to conduct Phase II trials in these indications in 2026
AbbVie Beats Consensus
As for AbbVie’s earnings, the company reported that sales of Skyrizi and Rinvoq continue to push the pharma’s revenue over analyst consensus, with an assist from the neuroscience and eye care franchises. At the same time, Humira sales continued its decline in the face of biosimilar competition, and sales in the aesthetics portfolio were notably lower than expected.
“Despite the setback with emraclidine in late 2024, AbbVie continues to have one of the cleanest revenue growth stories in the biopharma space over the next five years, driven by the dominance of Skyrizi and Rinvoq,” William Blair’s analysts said in a note ahead of the earnings call on Friday morning.
AbbVie booked $15.1 billion in sales for the fourth quarter, which was above the expectation of Guggenheim analysts who had predicted $14.85 billion. Full-year revenue was $56.334 billion, which is up 3.7% compared to the year prior. Skyrizi and Rinvoq brought in $11.718 billion and $5.971 billion globally for the full year, respectively, while Humira earned the company just under $9 billion for the full year.
The neuroscience portfolio also collected about $9 billion, which was an increase of 16.6% over the prior year. The aesthetics portfolio declined 2.2% to $5.176 billion.
Earnings per share (EPS) hit $2.16, compared to an estimate of $2.06. AbbVie is expecting EPS of $12.12 to $12.32, compared to Guggenheim’s prediction of $11.93.
