AbbVie 8-K

Summary

Q1 2026 results with raised FY2026 adjusted diluted EPS guidance. Revenue grew 12.4% reported, led by immunology and neuroscience, while GAAP diluted EPS fell 45.8%. AbbVie also reported FDA approval of the Venclexta–acalabrutinib regimen for previously untreated chronic lymphocytic leukemia and a complete response letter for trenibotulinumtoxinE requesting manufacturing information, with no safety or efficacy concerns identified.

Key Figures

• Portfolio revenue: immunology $7.29B (+16.4% reported; +14.3% operational), neuroscience $2.88B (+26.0%; +24.3%), aesthetics $1.19B (+7.6%; +5.1%), and oncology $1.63B (-0.2%; -3.0%). Skyrizi revenue was $4.48B (+30.9% reported) and Rinvoq was $2.12B (+23.3%); Humira was $688M (-38.6%).
• Acquired IPR&D and milestones expense was $744M pre-tax and $738M after tax, an unfavorable $0.41 per diluted share in both GAAP and adjusted results. A $2.39B pre-tax adjustment for the change in fair value of contingent consideration also affected the GAAP-to-adjusted comparison.
• AbbVie announced a $1.4B pharmaceutical manufacturing campus in Durham and a $380M investment in two North Chicago active pharmaceutical ingredient facilities.

Guidance

• FY2026 adjusted diluted EPS guidance: $14.08–$14.28, raised from $13.96–$14.16. The range includes a $0.41 per-share unfavorable impact from acquired IPR&D and milestones expense incurred through Q1; it excludes such expenses after Q1 because they cannot be reliably forecast.

Investor Takeaways

• FDA decision on Skyrizi subcutaneous induction for Crohn’s disease is expected later in 2026.
• AbbVie expects to respond to the trenibotulinumtoxinE FDA letter in the coming months; the FDA requested manufacturing information, not additional clinical studies.